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"It felt like armageddon" - Theo PA news editor Theo Usherwood and PoliticsJOE editor Ava-Santina Evans join @MattBarbet on #TheWrap# to discuss the numerous wildfires tearing through the nation and give their take on yesterday's government-issued severe emergency alert.
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What's making tomorrow's newspaper front pages? 📰 @jonathansamuels is joined by journalist and broadcaster @jennykleeman and political commentator @adamboultonTABB on #TheWrap#. 📺 Sky 501 and YouTube or follow the latest here:
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Destin Daniel Cretton reveals he turned down AVENGERS: DOOMSDAY after feeling he wasn’t the right fit. “When I told Kevin Feige, he mentioned ‘Spidey’… which was a huge relief.” Five to six months later, Amy Pascal offered him SPIDER-MAN: BRAND NEW DAY, despite there not yet being a script. (via TheWrap)
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therapist when they see a guy with Ethereum tatoo walking in
therapy for thresh haters
Therapy is in session 🪩 @flolikethis' sophomore album THERAPY AT THE CLUB is out now
"Therapy is expensive. Being funny and traumatized is free." 🌱
Therapist: Linear Mandarin is not real, it cannot hurt you. Linear Mandarin:
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Electra Therapeutics filed for an IPO, capitalizing on the strong performance of this year’s crop of biotechnology listings to fund its clinical stage pipeline of drugs to treat immune-mediated diseases and cancer
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Capricor Therapeutics faces an FDA target date on Saturday for a Duchenne muscular dystrophy therapy. On 13th August its chief executive closed the quarterly call by declining to take questions. “Lastly, due to the sensitivity of our ongoing discussions with the Food and Drug Administration, we are not holding a Q&A today.” The next day Capricor filed its quarterly report. The leases note carries a date that says what management expects. It signed a San Diego headquarters lease on 9th July that either side can terminate if the FDA has not approved by 31st December. To value it, Capricor had to pick a date on which the approval question resolves. It picked 22nd August 2026, which the filing calls “management’s best estimate of the date on which the FDA approval contingency will be resolved.” A $76.3 million right of use asset rests on that assumption. The same filing cuts against that. Capricor plans to submit an amendment with 24 month data, and says the FDA “has indicated it is willing to review this amendment and, upon receipt, to extend the PDUFA action date accordingly.” That amendment has not been disclosed as submitted. The lease note was not adjusted for the possibility. On 29th July an advisory committee voted 9 to 3 that the evidence did not establish effectiveness for the heart condition. The vote was narrow, was not on the trial’s main result, and is not binding. Two weeks later, after peer review, Capricor restated the heart measure from p 0.04 to p 0.09. Because it sat above the others in the prespecified testing order, everything below it is now reported as nominal. The primary upper limb result, p 0.029, was unaffected. A PDUFA date is a user fee goal, not a legal deadline, and the FDA does not publish extensions. Only the company can say where it stands. It last said anything on 14th August.
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