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Shanaka Anslem Perera ⚡
@shanaka86
Author of The Ascent Begins. Independent Analyst. Money, geopolitics, AI, science, and sovereignty. Trying to understand the reality a bit better.
参加 July 2009
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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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