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.
I know, I saw the abstract. I just want more. (I am not sure about whether hand injection will stop scleroderma progression.)
When you say the trial is nearing completion, do you mean nearing enrollment completion? When will we get preliminary data on it, do you know?
Would like to see the actual paper or poster, though.
Also (being the devil's advocate here, but would Cytori need to run placebo-controlled double-blind trials to get this approved in the US/Europe, or does the mechanical device approval cover that fully? Finally, do scleroderma symptoms ever go back down on its own -- will insurers pay?
I think Cytori mentioned 2018 as launch. I wonder if they really need another two years for this.