Replies to post #243230 on Biotech Values

[WorstLuck]

No FDA advisory panel is expected... This is surprising in that APLS’ pivotal trial missed its primary endpoint.

Several possibilities here.

1. There will be a panel and the company is 'wrong'.
2. It's likely DOA but the FDA needs to review (can't RTF) and may decide to have a panel later.
3. There is something interesting in the filing. Again, this may lead to a panel later.

2 & 3 are very similar and there may be no way to distinguish between them.

I don't follow that company closely enough to have a view. But for general purposes I propose that the drug will not be approved without a panel convening.