RE: RE: RE: Another InterpretationHere is the FDA review process for those who wish to review it.
https://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm
The FDA, if it does not approve, issues a complete response letter. As indicated in the excerpt I will post after this, the issues raised in a CRL can be minor (just need more information or something clarified) or it can be major (more studies required). Now if it were not for ISA's and Lux’s comments that they are not expecting more communication until they get the action letter I would have read the FDA statement as saying “we might issue our action letter in time for the original PDUFA date (i.e. a CRL) but we might instead extend the PDUFA date and reschedule the advisory committee meeting (i.e. approval still possible in this cycle, we just don’t know yet)” - how else does it make sense to be speaking about the review continuing and the possibility of holding a meeting still.
However, from what Lux is saying (and from what biorunup post says ISA is saying i.e. they are expecting an action letter not just a request for information) it sounds like Lux and ISA are not expecting any communication other than the action letter. If that is the case then clearly the action letter will not be an approval, it will be a CRL. Maybe Lux is wrong and/or ISA is misinterpreting what Lux is saying. Anyway, if they are right and we are going to get an action letter, it will therefore be a CRL. The thing we can’t know and won’t know until the CRL is issued is what those issues are – of that I have no idea. On the positive sign I don’t have the same concern I had posted earlier that we would be sent back to square one without, possibly, priority review – it sounds to me that like the application is not a fresh submission but just a new cycle of the original so in some ways a continuing process. On the negative side, again, we don’t know what the issues are and maybe they are major or (just as bad) minor but will take a long time to resolve.