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.
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.
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?
That is not true in any way. They had an IPO last year at $11, and a convertible offering in February to raise cash. The convertible price per share is $14.83.
Er, a short attack? What do you think happened here already? It went from high $16s to $6.
Well, yes... as you could probably tell, I am long. Actually the question is abuse-deterrent labeling... in other words, can the product hypothetically deter abuse in any way?... I think the answer is "yes".