- 2023 Final Four: Evaluating UConn, Miami, San Diego State, FAU as March Madness heads to Houston CBS Sports
- Final Four field is totally nutty, but UConn’s fifth men’s title won’t be a strange outcome at all Chicago Sun-Times
- Miami, San Diego State Join a Men’s Final Four That Is Missing the Top Seeds The Wall Street Journal
- 2023 Final Four odds, lines: UConn, San Diego State open as favorites, Huskies favored to win NCAA Tournament CBS Sports
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Tag Archives: Evaluating
NFL whiffed on evaluating Tyler Huntley before the 2020 draft
It’s too early to say for sure what kind of career Ravens quarterback Tyler Huntley will have. But Huntley has done enough this season that it’s not too early to say that NFL talent evaluators significantly underestimated him in the 2020 draft.
The 23-year-old Huntley has started two games for the Ravens this season and played most of another, when Lamar Jackson exited early in Cleveland with an ankle injury, and Huntley has played about as well as Jackson has: Huntley has a slightly higher passer rating than Jackson, 88.8 to 87.0, and Huntley and Jackson average an identical 5.8 yards per carry running the ball.
Huntley is fast, good at recognizing the pass rush and using his legs to get out of trouble, and has a good arm. A player with his talent at the NFL’s most important position is obviously worth taking a chance on in the draft, and yet Huntley went undrafted in 2020.
But Huntley didn’t only go undrafted. He wasn’t even invited to the Scouting Combine, not even as one of the extra quarterbacks who goes to the Combine to throw passes in the receiver drills. Several quarterbacks who were invited to the Combine in 2020 have already washed out of the NFL and were watching on their couches as Huntley threw for two touchdowns and ran for two more on Sunday against the Packers.
And it’s not like Huntley was some nobody in college. He was a three-year starter at Utah who was chosen first-team All-Pac-12 in 2019 — chosen over, among others, Oregon quarterback Justin Herbert, who went sixth overall in the 2020 draft to the Chargers and is now one of the best quarterbacks in the NFL.
It would be tempting to credit the Ravens for being the one team that recognized Huntley’s talent, but the Ravens really didn’t recognize it either. If they had, they would have drafted him. Instead they brought him to camp only as an undrafted free agent, then they put him on waivers at the end of training camp, giving any other team a chance to claim him, and then for most of his rookie season they left him on their practice squad, where any other team could have signed him away.
If the Ravens had any idea that Huntley would play the way he’s playing this, they never would have risked losing him last year.
It might sound like 20/20 hindsight to say Huntley should have been drafted in 2020, but there were some people saying so before the 2020 draft. Paul Noonan wrote for SB Nation a week before the draft that Huntley was the best late-round prospect in the draft at any position, and that Huntley actually should be thought of as “one of the best prospects in the class and not some late-round flier.” And although the use of analytics for determining which players to draft is still in its infancy, it’s worth noting that several people who attempt to use analytics to evaluate draft prospects were very high on Huntley a year and a half ago.
A whole lot of teams wish they could have a do-over in 2020 and spend a draft pick on Huntley. It’s too late for that, but smart teams are surely examining how they whiffed on Huntley, and vowing not to repeat the mistake of letting a talented quarterback go undrafted.
1-32 poll, plus evaluating the job security of every team’s coach
The NFL Power Rankings are a bit off-kilter this week, as two games from Week 15 (Seattle Seahawks at Los Angeles Rams and Washington Football Team at Philadelphia Eagles) were delayed until 7 p.m. ET Tuesday and won’t be accounted for below. Such are the times of COVID-19.
But what the Power Rankings do account for this week is a bit of a holiday tradition: coaching speculation. The homestretch of the season isn’t just a big time for playoff prognostication; it’s also key to the futures of coaches who are on the “hot seat.” So, we decided to dedicate this week’s rankings to identifying how much danger each coach is in. We came up with four categories for our NFL Nation writers to identify how hot each coach’s seat is:
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4. Hot seat: Headed out if things don’t turn around by season’s end.
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3. Warm seat: Not safe if season ends in disappointment.
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2. Cool seat: Safe barring total disaster down the stretch.
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1. Cold seat: No way he’ll get fired.
Two coaches have already been removed — Jon Gruden with the Las Vegas Raiders and Urban Meyer with the Jacksonville Jaguars — so we assessed the status of their interim coaches, plus that of the 30 other coaches.
How we determine our Power Rankings: Our power panel — a group of more than 80 writers, editors and TV personalities — evaluates how teams stack up throughout the season.
Previous rankings: 15 | 14 | 13 | 12 | 11 | 10 | 9 | 8 | 7 | 6 | 5 | 4 | 3 | 2 | Preseason
Jump to:
ARI | ATL | BAL | BUF | CAR | CHI | CIN
CLE | DAL | DEN | DET | GB | HOU | IND
JAX | KC | LV | LAC | LAR | MIA | MIN
NE | NO | NYG | NYJ | PHI | PIT | SF
SEA | TB | TEN | WSH
Previous ranking: 3
How hot is Matt LaFleur’s seat: 1. Cold seat
Three division titles in three seasons. That pretty much says everything that needs to be said. If anything, LaFleur is in line for a contract extension and should be one of the favorites for NFL Coach of the Year — as the Packers quickly overcame an embarrassing, 38-3 season-opening loss to the Saints, and they now are in line to grab home-field advantage in the playoffs. — Rob Demovsky
Previous ranking: 4
How hot is Andy Reid’s seat: 1. Cold seat
The Chiefs are on the verge of winning their sixth straight AFC West crown, and they control their own destiny toward winning the AFC’s top playoff seed. So they’re going to fire Reid? Not a chance. Remember that in the five seasons before his arrival, the Chiefs had two two-win seasons and two other campaigns with four wins each; at 10-4, they’re on track to win more than those 12 games this season alone. — Adam Teicher
Previous ranking: 1
How hot is Bruce Arians’ seat: 1. Cold seat
The Bucs’ offense might have gone absolutely nowhere in Tampa Bay’s 9-0 home loss to the Saints on Sunday night, but Arians is just one season removed from a Super Bowl title, and Tom Brady is putting up some of the best numbers of his career at age 44. As much as the coaching staff deserve blame for the implosion against the Saints, they also deserve a ton of credit for helping this team win 10 games despite being decimated in the secondary. — Jenna Laine
1:40
Dan Orlovsky explains why Dak Prescott and the Cowboys’ offense need to play better to make a serious playoff run.
Previous ranking: 6
How hot is Mike McCarthy’s seat: 1. Cold seat
The campaign might not have started out that way after last season’s 6-10 finish, but McCarthy has the Cowboys poised to clinch the NFC East title and perhaps the top seed in the playoffs. He has managed a team that has dealt with injuries and COVID-19. He has had some eyebrow-raising moments with his clock management, at times, but he has done a good job of making sure the players have been physically and emotionally ready to play a 17-game season. Ultimately, he will be judged by what the Cowboys do in the postseason, but there’s no question about his status going into 2022. — Todd Archer
Previous ranking: 5
How hot is Bill Belichick’s seat: 1. Cold seat
Prior to the Week 15 loss at Indianapolis, Belichick was a leading candidate for NFL Coach of the Year honors as a result of having the Patriots among AFC playoff contenders in a season with rookie quarterback Mac Jones leading the way. Few saw that coming. A major offseason overhaul with a huge free-agent spending spree has sparked the turnaround, and as a result, Belichick’s job is as secure as it’s ever been in his 22nd season. — Mike Reiss
Previous ranking: 8
How hot is Sean McVay’s seat: 1. Cold seat
McVay is 52-25 and has won two division titles and an NFC championship since the Rams named him as the youngest head coach in modern NFL history in 2017. In McVay’s five seasons, the Rams have made the playoffs three times. And they are well on track to earn a fourth playoff berth and potentially a third division title under McVay this season. There’s no reason to think he would not be more than welcome to return in 2022, even if the Rams fall short of a trip to a hometown Super Bowl in February. — Lindsey Thiry
Previous ranking: 2
How hot is Kliff Kingsbury’s seat: 2. Cool seat
This is an interesting question, because a few weeks ago, Kingsbury’s seat was super cold — like ice cold, as Outkast put it. But falling to the Lions on Sunday in the fashion the Cardinals did, which continued a slide of losing four of their past seven games, has warmed Kingsbury’s seat a little. If the Cards have a third straight late-season collapse and it affects their playoff seeding dramatically, Kingsbury could possibly be out in Arizona, although 10 wins and a playoff berth is likely enough to keep him. But it’ll depend on how bad it gets from now until they’re eliminated from the postseason. — Josh Weinfuss
Previous ranking: 7
How hot is Mike Vrabel’s seat: 1. Cold seat
Vrabel has won at least nine games in each of his first four seasons, and his .606 win percentage is the fourth highest in Titans/Houston Oilers franchise history. The Titans made a run to the AFC Championship Game in 2019. Last season, Vrabel led the Titans to their first AFC South title since 2008. Despite rostering an NFL-record 88 players on game day this season, Vrabel has the Titans well within reach of a second AFC South crown. — Turron Davenport
Previous ranking: 9
How hot is Sean McDermott’s seat: 1. Cold seat
This could be a cool seat, instead, because of the expectations going into the season for the Bills, but McDermott isn’t going anywhere. If the team manages to beat the Patriots and win the AFC East, it will be a solid coaching performance for McDermott. There certainly have been some tough and questionable moments this season, but McDermott will have multiple chances to take this team on playoff runs. — Alaina Getzenberg
1:53
The Get Up crew shares it’s picks to win the NFL’s most valuable player.
Previous ranking: 13
How hot is Frank Reich’s seat: 1. Cold seat
The Colts are on the brink of making the playoffs for the third time in four seasons under Reich. And for the second time in those four seasons, Reich has gotten his team to rebound from a slow start. The Colts started this season 0-3 and 1-4, and now they’re currently the No. 5 seed in the AFC with an 8-6 record. I think it is safe to say Reich isn’t going anywhere. — Mike Wells
Previous ranking: 11
How hot is Kyle Shanahan’s seat: 2. Cool seat
Realistically, there’s almost no chance Shanahan is going anywhere after this season. But speaking in absolutes on anything NFL-related seems unwise, hence the tiniest bit of wiggle room for something unforeseen. Shanahan just signed a six-year contract extension in 2020 that will take him through 2025. The Niners are on a playoff trajectory, which would be a solid bounce back after a disappointing follow-up to their 2019 Super Bowl run. But ultimately, the Shanahan era is going to be defined by what happens in the coming years with him coaching and Trey Lance playing quarterback. That duo will be afforded an opportunity to see where they can go together. — Nick Wagoner
Previous ranking: 12
How hot is Brandon Staley’s seat: 1. Cold seat
The Chargers haven’t been to the playoffs since the 2018 campaign. This team turned around when quarterback Justin Herbert was drafted in 2020 and Staley arrived after the end of last season. The organization and the players are squarely behind the coach’s “going for it on fourth down” decisions — even when they don’t always work. He has a young, smart staff and talented players on both side of the ball. And most importantly, Staley has their trust. Everything down to the activation period (stretching and calisthenics) has been well-received and emulated around the league. — Shelley Smith
Previous ranking: 10
How hot is John Harbaugh’s seat: 1. Cold seat
There’s been plenty of debate over Harbaugh’s decisions to go for two points late in games, but the Ravens wouldn’t be in these contests if not for his coaching. Baltimore is 8-6 despite having 23 players on injured reserve at some point this season. Even if the Ravens don’t make the postseason, this has been one of Harbaugh’s more remarkable coaching performances in what has been a successful 14 seasons in Baltimore. Since Harbaugh became the Ravens coach in 2008, Baltimore has won 137 games. Only four teams (Patriots, Packers, Steelers and Saints) have won more over that span. — Jamison Hensley
Previous ranking: 14
How hot is Zac Taylor’s seat: 3. Warm seat
What’s the option between lukewarm and warm? Like a cup of coffee you poured roughly 20 minutes ago? Because that’s what Taylor’s situation feels like. Cincinnati got a much-needed win against Denver to stay in the playoff chase. And the Bengals’ hopes of being a postseason contender are still very much alive, as Cincinnati holds a share of the AFC North lead heading into Week 16. This team has already exceeded preseason expectations, and Taylor deserves ample credit for that. But there’s still some work to be done as the team closes out Taylor’s third season. — Ben Baby
Previous ranking: 16
How hot is Mike Tomlin’s seat: 1. Cold seat
A changing of the guard is coming in Pittsburgh, but Tomlin is staying put. Ben Roethlisberger will likely be making his exit after 18 campaigns at the conclusion of this season, and general manager Kevin Colbert could follow suit if he opts not to pick up another season on his year-to-year deal. But Tomlin signed a three-year extension in April. Though inconsistent at times, the Steelers are 7-6-1 and still in contention to win the AFC North with three weeks left — and that is a testament to Tomlin’s coaching ability. His messaging hasn’t always gotten through to his team before the game, but something is happening at halftime that has helped Pittsburgh to second-half surges. That something is Mike Tomlin. — Brooke Pryor
0:47
Dolphins defensive lineman Christian Wilkins did “the worm” after his touchdown, so Marcus Spears decides it’s his turn and does it in-studio.
Previous ranking: 18
How hot is Brian Flores’ seat: 2. Cool seat
Flores’ seat would’ve been much hotter were it not for the team’s recent six-game winning streak that has catapulted Miami back into playoff contention. Even if the Dolphins lose out from here, it’s unlikely Flores goes anywhere. Next season, however, his seat will heat up fast if they get off to another slow start for the third season in a row. — Marcel Louis-Jacques
Previous ranking: 22
How hot is Sean Payton’s seat: 1. Cold seat
Payton’s job is perfectly secure — despite the fact that New Orleans just had one of its most impressive wins of the season without him on Sunday while he was sidelined by COVID-19. The Saints’ passing offense has fallen flat this season for the first time since Payton arrived in 2006. But overall, their 7-7 record is decent considering all the attrition they’ve faced with injuries, Drew Brees’ retirement and salary-cap cuts. The team might have to consider a significant roster rebuild in the near future, but the coaching staff remain a strength. — Mike Triplett
Previous ranking: 15
How hot is Kevin Stefanski’s seat: 1. Cold seat
The Browns have been up and down in Stefanski’s second season, in large part due to injuries and COVID-19 issues. But the reigning NFL Coach of the Year is in no danger of losing his job after taking the Browns to their first playoff appearance in 18 years last season and helping them to their first playoff victory since the 1994 season. — Jake Trotter
Previous ranking: 21
How hot is Mike Zimmer’s seat: 4. Hot seat
The Vikings have not missed the playoffs in back-to-back seasons since Zimmer took over in 2014. If they don’t make it this season, it’s hard to see Zygi and Mark Wilf wanting to continue the course with Zimmer at the helm despite the coach having two years remaining on his contract. Zimmer’s defense never truly bounced back in 2021 after the copious number of resources that were poured into retooling this once-vaunted unit, and the abundance of one-score games the Vikings have played in this season might make the Wilfs want to get off the roller coaster. — Courtney Cronin
Previous ranking: 17
How hot is Vic Fangio’s seat: 3. Warm seat
George Paton hasn’t completed his first season as the Broncos general manager, so it’s not completely clear how he will react to the season Denver is having. It’s not known if he will elect to replace the entire coaching staff or keep Fangio with the caveat that the coach has to make changes on the staff — especially on the team’s still-struggling offense. Paton has publicly said how much he respects Fangio and believes they work well together on personnel and the development of young players. Fangio also calls plays for the No. 2 scoring defense in the league. But without a holiday football miracle, this will be the sixth consecutive season the team has missed the playoffs and scored fewer than 23 points a game — and the team’s faithful are fresh out of patience. — Jeff Legwold
Previous ranking: 23
How hot is Rich Bisaccia’s seat: 4. Hot seat
Shy of a Steve Fisher-esque 1989 postseason run (look up Michigan Wolverines, hoops fans), Bisaccia, the interim coach, is on his way out. He won his first two games after replacing Jon Gruden but had five losses in his next six games — to go from 5-2 to 6-7 — which all but sealed the deal. Some names that are already being bandied about by Raiders fans and media: Jim Harbaugh, Dabo Swinney, Mike Tomlin, David Shaw, Doug Pederson, Eric Bieniemy, Kellen Moore. Buckle up. — Paul Gutierrez
Previous ranking: 19
How hot is Ron Rivera’s seat: 1. Cold seat
In Rivera’s first season, Washington overcame a 2-7 start to win the NFC East at 7-9; the division was bad, but Washington played well down the stretch. That banked goodwill for Rivera. This season, with higher expectations, Washington again started slow but climbed back into playoff contention with a four-game win streak. Injuries and COVID-19 could end up derailing Washington’s campaign, but there’s no doubt Rivera has earned a third season. The team will have to show even more progress next season for him to remain on a cold seat, but there’s reason for optimism moving forward. — John Keim
Previous ranking: 20
How hot is Nick Sirianni’s seat: 1. Cold seat
There were some shaky moments early in the season, but Sirianni has since found his footing in his first year. He shifted his approach on offense to more of a ground-based attack starting in Week 8. Since then, the Eagles are second in points per game (29.7), first in third-down efficiency (51.2%) and third in explosive plays (65), according to the team. Philadelphia (6-7) has won four of six games over that span and is now right in the thick of the playoff race. Sirianni has shown growth and a willingness to adapt, and he managed to keep his players on board despite a rocky 2-5 start. He has earned another year at the helm. — Tim McManus
Previous ranking: 24
How hot is Arthur Smith’s seat: 1. Cold seat
Smith is in his first year as a head coach. The Falcons are still in the playoff race despite a roster hamstrung by salary-cap issues. The Falcons missed the playoffs the previous three seasons, and they went 4-12 in 2020. If there was a zero option, it would be here. There’s no reason to think Arthur Smith won’t return in 2022. — Michael Rothstein
Previous ranking: 25
How hot is Pete Carroll’s seat: 2. Cool seat
Observers who talk about the possibility of Seattle firing Carroll seem to forget the Seahawks gave him a five-year extension in the fall of 2020. If one lousy season was all it would take for Jody Allen to lose faith in him then the team’s de facto owner probably wouldn’t have given him a deal three years longer than his previous one. And while Carroll is ultimately responsible for the miserable start by the Seahawks’ defense, Allen could conceivably chalk this up as a season done in by Russell Wilson’s injury more than anything. However, Allen has been a massive mystery since taking control of the team in 2018, so no one knows what she could be thinking. But conventional wisdom says Carroll’s contract and his track record before this season will give him security. — Brady Henderson
Previous ranking: 26
How hot is Matt Rhule’s seat: 3. Warm seat
It could shift to the hot seat if the Panthers lose their next three to end on a seven-game skid and with only five wins for a second straight season under Rhule. Team owner David Tepper gave Rhule a seven-year deal because he knew the rebuild could take time, but expectations seemed to change after a 3-0 start. Ultimately, poor decisions at quarterback (Teddy Bridgewater, Sam Darnold, Cam Newton) and with offensive coordinator Joe Brady have Rhule and his staff in a bind for the future. Tepper likely won’t pull the plug this season, but the lack of improvement down the stretch over two straight campaigns might change that. — David Newton
Previous ranking: 27
How hot is Joe Judge’s seat: 3. Warm seat
It’s actually starting to get warm as the losses pile up even though Judge is in his second season. The Giants don’t want to continue this vicious cycle of firing coaches every two years. They already did it with Ben McAdoo and Pat Shurmur. Team co-owner John Mara has admitted regret for cutting it off so quickly with McAdoo and as recently as midseason still was a full believer in Judge. It makes it hard to believe the Giants would fire Judge after this season, unless it only gets worse in the final few weeks. — Jordan Raanan
Previous ranking: 28
How hot is Matt Nagy’s seat: 4. Hot seat
Speculation has been brewing for months, and the expectation after another losing season is that the Bears will move on from Nagy in a matter of weeks. Nagy was hired in 2018 with the belief he would ignite Chicago’s offense. That hasn’t happened — the Bears have scored the eighth-fewest points in the NFL under his leadership — nor has rookie quarterback Justin Fields’ development gone according to plan. Nagy’s handling of playcalling duties has been troublesome this season, and the 295 points Chicago surrendered in its 10 losses make it unlikely that ownership does anything but hit the reset button this offseason. — Courtney Cronin
Previous ranking: 31
How hot is Dan Campbell’s seat: 2. Cool seat
Obviously, nothing is guaranteed in the NFL. But even with the disappointing record in his first season, the Lions’ players and front-office members absolutely love Campbell and work hard for him. He has made mistakes, notably when he was first adjusting to taking over the playcalling role, but Campbell’s effort and intensity have been consistent, which is how he has earned his respect. It’s no secret that the Lions are in the midst of yet another rebuild, and Campbell didn’t enter a situation with a ton of talent, but he is trying to make the most of what he has while building a culture with toughness and grit at the forefront. — Eric Woodyard
Previous ranking: 32
How hot is David Culley’s seat: 3. Warm seat
The Texans have just three wins this season — two against the lowly Jaguars — and likely won’t even get the No. 1 overall pick. Culley admitted during Monday’s news conference that general manager Nick Caserio instructed him to let the Patriots score as they approached the red zone back in Week 5 to give Houston’s offense a chance to reply with more time on the clock instead of 15 seconds — which the Texans coach said he “didn’t compute.” If Caserio has that much say over in-game strategy, it’s fair to wonder if he thinks it’s worth having Culley stay on as head coach. Caserio might already have his mind made up regarding 2022, and it’s very possible that it doesn’t include Culley. — Sarah Barshop
Previous ranking: 29
How hot is Robert Saleh’s seat: 1. Cold seat
Saleh, who inherited one of the worst rosters in the league, is finishing up Year 1 in a major youth movement. This is a long-term rebuild, which should start to bear fruit in 2022. His defense is historically poor — and some of that falls on him — but Saleh is doing a good job of galvanizing the organization with his upbeat demeanor. The negativity is testing him in ways he never imagined. — Rich Cimini
Previous ranking: 30
How hot is Darrell Bevell’s seat: 4. Hot seat
Team owner Shad Khan fired Urban Meyer last week, and now it’s Khan who is on the hot seat. He has missed on every coaching/GM hire he has made in the 10 years he has owned the team, and he better get this one right. QB Trevor Lawrence’s future is at stake, and if Khan blows this hire, it might set the franchise back another decade. — Mike DiRocco
Ocugen, Inc. Announces Submission of Investigational New Drug Application with U.S. FDA to Initiate a Phase 3 Clinical Trial Evaluating COVID-19 Vaccine Candidate COVAXIN™ (BBV152)
The Phase 3 study is designed to bridge data collected from the vaccine efficacy trial conducted in India to the U.S. population
MALVERN, Pa., Oct. 27, 2021 (GLOBE NEWSWIRE) — Ocugen, Inc. (NASDAQ: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced that it has submitted an Investigational New Drug application (IND) with the U.S. Food and Drug Administration (FDA) to evaluate the COVID-19 vaccine candidate, BBV152, known as COVAXIN™ outside the United States.
COVAXIN™ is a whole-virion inactivated COVID-19 investigational vaccine candidate that uses the same vero cell manufacturing platform that has been used in the production of polio vaccines for decades.
The Phase 3 trial proposed in the IND is designed to establish whether the immune response experienced by participants in a completed Phase 3 efficacy trial in India is similar to that observed in a demographically representative, healthy adult population in the U.S. who either have not been vaccinated for COVID-19 or who already received two doses of an mRNA vaccine at least six months earlier.
“We are very excited to take this next step in the development of COVAXIN™, which we hope will bring us closer to introducing a different type of COVID-19 vaccine to the American public,” said Dr. Shankar Musunuri, Chairman of the Board, Chief Executive Officer, and Co-Founder of Ocugen. “We are hopeful that the study conducted under the IND, if allowed to proceed, will help demonstrate that the data from India will be applicable to the U.S. population.”
If the study is allowed to proceed, Ocugen’s Phase 3 immuno-bridging study, OCU-002, will seek to enroll several hundred healthy adults in the U.S. Subjects will be randomized to receive either two doses of COVAXIN™ or placebo, 28 days apart. The primary endpoint will compare blood-based samples taken from U.S. participants who received COVAXIN™ with samples of the participants in the Phase 3 efficacy trial conducted in India. The secondary endpoint involves testing the vaccine’s immunogenic profile. The study will also evaluate safety and tolerability in the U.S. population. Ocugen hopes to complete the study during H1 2022.
The Phase 3 study conducted in India by Ocugen’s business partner, Bharat Biotech, involved 25,798 participants receiving two doses of COVAXIN™ or placebo, 28 days apart. The primary endpoint was preventing symptomatic COVID-19 occurring at least 14 days after the second dose. Results of the trial found 93.4% efficacy against severe COVID-19 disease, 77.8% efficacy against symptomatic COVID-19 and 63.6% efficacy against asymptomatic disease. A sub-analysis of the Phase 3 study examined the presence of infections by variants of the original coronavirus strain. Overall, 90% of infections showed the presence of a variant, with 59% of those being the Delta variant. The sub-analysis revealed COVAXIN™-treated patients experienced 65.2% efficacy against the Delta variant. Adverse events reported in the trial included pain, erythema, induration, swelling, headache, pyrexia, fatigue, chills, myalgia, arthralgia, nausea and vomiting. 12.4% of subjects experienced an adverse event in both the COVAXIN™ and placebo arm. Additionally, 0.3% of subjects in the COVAXIN™ arm experienced a serious adverse event compared to 0.47% of patients in the placebo arm.
About COVAXIN™ (BBV152)
COVAXIN™ (BBV152) is an investigational vaccine candidate product in the U.S. It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). COVAXIN™ is a highly purified and inactivated vaccine that is manufactured using a vero cell manufacturing platform.
With more than 100 million doses having been manufactured, COVAXIN™ is currently being administered under emergency use authorizations in 17 countries, and applications for emergency use authorization are pending in more than 60 other countries. The trade name COVAXIN™ has not been evaluated by the FDA.
About Ocugen, Inc.
Ocugen, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with one drug – “one to many” and our novel biologic product candidate aims to offer better therapy to patients with underserved diseases such as wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. We are co-developing Bharat Biotech’s COVAXIN™ vaccine candidate for COVID-19 in the U.S. and Canadian markets. For more information, please visit www.ocugen.com.
About Bharat Biotech
Bharat Biotech has established an excellent track record of innovation with more than 145 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 123 countries, and the World Health Organization (WHO) Pre-qualifications. Located in Genome Valley in Hyderabad, India, a hub for the global biotech industry, Bharat Biotech has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.
Having delivered more than 4 billion doses of vaccines worldwide, Bharat Biotech continues to lead innovation and has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika, and the world’s first tetanus-toxoid conjugated vaccine for Typhoid. Bharat’s commitment to global social innovation programs and public-private partnerships resulted in introducing path-breaking WHO pre-qualified vaccines BIOPOLIO®, ROTAVAC®, and Typbar TCV® combatting polio, rotavirus, typhoid infections, respectively. The acquisition of the rabies vaccine facility, Chiron Behring, from GlaxoSmithKline (GSK) has positioned Bharat Biotech as the world’s largest rabies vaccine manufacturer. To learn more about Bharat Biotech, visit www.bharatbiotech.com.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such forward-looking statements include information about qualitative assessments of available data, potential benefits, expectations for clinical trials, and anticipated timing of clinical trial readouts and regulatory submissions, including with respect to our hope that the Phase 3 trial included in our Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA) for COVAXIN™, if allowed to proceed, will be completed during the first half of 2022, or that the results of any such trial may demonstrate that existing data from Bharat Biotech’s clinical trials in India for COVAXIN™ will be applicable to the U.S. population. This information involves risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preliminary and interim data, including the possibility of unfavorable new clinical trial data and further analyses of existing clinical trial data; the risk that the results of in-vitro studies will not be duplicated in human clinical trials; the risk that clinical trial data are subject to differing interpretations and assessments, including during the peer review/publication process, in the scientific community generally, and by regulatory authorities; whether and when data from Bharat Biotech’s clinical trials will be published in scientific journal publications and, if so, when and with what modifications; whether the FDA will accept our IND submission without any changes, or if we are required to submit additional information to the FDA in support of our IND submission, the extent and significance of any such changes; whether we will be able to provide the FDA with sufficient additional information regarding the design of and results from preclinical and clinical studies of COVAXIN™, which have been conducted by Bharat Biotech in India in order for those trials to support a biologics license application (BLA); the size, scope, timing and outcome of any additional trials or studies that we may be required to conduct to support a BLA, including our planned Phase 3 clinical trial for which we have submitted an IND to the FDA; any additional chemistry, manufacturing and controls information that we may be required to submit at the time of our BLA filing; whether developments with respect to the COVID-19 pandemic will affect the regulatory pathway available for vaccines in the United States, Canada or other jurisdictions; market demand for COVAXIN™ in the United States or Canada; decisions by the FDA or Health Canada impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of COVAXIN™ in the United States or Canada, including development of products or therapies by other companies. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events or otherwise, after the date of this press release.
Ocugen Contact:
Ken Inchausti
Head, Investor Relations & Communications
ken.inchausti@ocugen.com
Please submit investor-related inquiries to: IR@ocugen.com
TPG Is Evaluating a Public Listing
TPG, one of the last of the original private-equity giants to remain a closely held partnership, is evaluating a public listing, people familiar with the matter said.
The firm is considering a straightforward initial public offering and a merger with a special-purpose acquisition company, with the former being the most likely route, the people said. Such a deal could value the California-and-Texas firm at about $10 billion, some of the people said.
The process is still in its early stages and TPG may not opt to proceed with any deal.
TPG, with nearly $100 billion in assets under management, has flirted with an IPO multiple times, only to end up balking while rivals forged ahead. Blackstone Group Inc., Apollo Global Management Inc., KKR & Co. and Carlyle Group Inc. went public years ago, transforming businesses that have enjoyed rapid growth as the industry is flooded with assets.
“As we have consistently stated, we evaluate various strategic alternatives from time to time,” a TPG spokesman said in a statement. “No decisions have been made and we have nothing to announce at this time.”