Re: No mention of efficacy again...
in response to
by
posted on
Mar 29, 2019 03:41PM
Yes, you were understanding my thought process correctly.
Your list of milestones is good. There is uncertainty as to how much info will be in the top-line data. Most CVOTs don't give a %RRR in the top-line and instead wait for full data reveal; however some, like Amarin, gave the %RRR for their primary 5-point MACE outcome in the top-line but waited for full data to reveal the 3-point MACE secondary outcome. It is also uncertain whether results of the CKD or cognition sub-studies will be revealed at top-line or a later date such as full data presentation. There could also be a steady flow of data including results of pre-specified analyses of the primary MACE outcome as well as CKD and cognition sub-studies that come later after the initial full data reveal for the primary MACE outcome.
As for the FDA review, you wrote "But it can still take 6-9 months for actual FDA approval right, ... after full data, and application to the FDA?"
Correct. Several months after NDA application for FDA approval. In the 6-10 month range. On the shorter end if granted priority review. However, I think the clock starts after the FDA decides whether the filing has been accepted, which itself can take 60 days. Here's a page from the FDA.
BearDownAZ