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?
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".
You have a wide variety of factors here. Yes, they have a lot of cash, management and some directors continue to buy shares in quantity, but the continual failure of management to live up to expectations, while pushing back commercialization, is really hurting the stock. It does not help that management is very highly paid for this kind of performance.
IBB also falling.
Also, I just want to make sure people understand that there is no review committee here; it is a meeting with the FDA reviewers to understand why they issued a CRL. So again, they might change their mind but there is no language in the law for them to do so, at least until there is a formal request for a hearing of the decision.