But, regardless, it is still good for rlyp to have even an extra 2-month lead.
I think DDI data is likely. (2) is not likely. The PR explicitly stated this was a manufacturing-related CRL. In my opinion it is to do with certification, etcetera, and will be resolved in two months.
Lately, the FDA has been issuing manufacturing CRLs that are very easily resolved. See CHMA latest CC. Won't let me post the whole thing here.
That is all we have to go by for now though, other than speculation. Speculation usually does not drive away shorts.
Okay, so it is a potential manufacturing issue which can be resolved in a couple of months very easily with simple clarification.
You are right, the FDA can do whatever it wants really, in the moment, but it is not fair play to change the rules around mid-submission.
This cannot be the reason. A standard can only be identified when the NDA is accepted, and not when the decision is made.
Why did you buy this stock if you do not know that KP201/APAP is abuse-deterrent, and that they have a platform applicable to a number of very large markets?