"“As part of the ongoing review of our NDA for AXS-05, the FDA recently notified us that they have identified deficiencies that preclude labeling discussions at this time. We are attempting to learn the nature of these deficiencies with the goal of addressing them, however, this development may lead to a delay in the potential approval of AXS-05. We will keep you informed as we learn more,” said Herriot Tabuteau, MD, Chief Executive Officer of Axsome."
https://axsometherapeuticsinc.gcs-web.com/...d-quarter-2021-financial
Zahlen für Q2/21
- keine Umsätze
- Verlust 32 Mio. $
- Cash 141 Mio. $
"Axsome believes that its cash at June 30, 2021, along with the remaining committed capital from the $225 million term loan facility, is sufficient to fund anticipated operations, based on the current operating plan, which includes costs for the potential commercial launch of AXS-05 in MDD and AXS-07 in migraine, into at least 2024."
The Prescription Drug User Fee Act (PDUFA) target action date for the NDA is August 22, 2021.
Die FDA hat AXSM mitgeteilt, dass sie "Mängel festgestellt hat, die derzeit eine Diskussion über die Kennzeichnung ausschließen."Es wäre interessant zu wissen um welche Mängel es sich konkret handelt, eine Zulassungsverzögerung halte ich nun für sehr wahrscheinlich.
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