Athersys did a reverse split with dilution and it didn't lose value. So we shouldn't say R/S, we should say R/S with dilution -- I agree that this is typically the case. I would still like to see a R/S without dilution to shake off retail.
Then I would want a reverse split.
In theory a reverse split is just an accounting measure. It won't do anything to anyone's percent ownership of a company. However, those people afraid of the reverse split will bail and crash the price. That way, if some other news event comes along later, you no longer have these irrational investors that will then crash the price.
I would probably not invest in this company unless it did a reverse split and went on Nasdaq. It will shake off retail that is afraid of reverse splits.
So, it seems that people sold based on the concept that there was an expectation that the July 14 PDUFA would be actually today for some insane reason. What do you think about that?
It should have been way past time for the year's employee option pricing program to be announced.
He was appointed in April; the thinking at the time and likely up to mid-May and possibly even June was that abuse-deterrent labeling could be separated into different categories (and this is what the FDA's guidance says) and a Category 3 primary endpoint failure was not a death stroke. In fact, when those results were announced, I believe the stock shot up substantially.
One thing he may have had to do with is the unusual silence on the true content of the CRL (and inexcusable in my view). It is possible he is actually weakening the company with his advice. I saw that Linkedin profile with someone praising him for being an important part of J&J's acquisition of Mentor, although that's not provable... In any case, all speculation, really.
The drug is viewed by the company as worthless if it does not get an abuse-deterrent label.
The FDA cannot approve a drug if they don't agree on that label with the company, so any other speculation is a moot point.
I do agree with that to a certain degree.
FDA guidance does stipulate individual categories of abuse-deterrence, right in the examples section. Even if they had just extraction resistance, it should have had abuse-deterrent labeling. Something is off here.
I suppose you read John Carroll's article. He is not a good journalist and should not be relied upon for accurate biotech reporting.
The FDA cannot approve a drug where they disagree with a company on labeling.
Alternatively, yeah, there is a now-slim hope here with the apparently unpredictable FDA to get Apadaz approved. I just think that if they get that constipation result and they get that overdose result from KP511, it doesn't matter what the FDA thinks of the abuse-deterrence labeling. The safety and side-effect results will speak for themselves. Similarly, if they can get KP415 patients managed with one pill for 24 hours, abuse-deterrence isn't important anymore and that one feature is quite enough.
I think they need to change their pipeline strategy and place KP511 before KP201. If KP201/APAP does not have abuse-deterrence, according to the FDA, what hope does just KP201/IR have? They said a few times they are exploring ways of adding physical abuse-deterrence, like Avridi (using sodium lauryl sulfate there), via partnering with other companies.
I think either KP415 or KP511 are really the best ideas here. KP511 can potentially eliminate opioid-induced constipation as well as provide incredible protection against oral overdose. That would be absolutely huge, since oral overdose is really the number one pathway of abuse and death. I suggested this approach to the company. Don't know if they will take it...
KP511 should have human proof-of-concept data within the next two weeks.
One more item for everyone. If FDA approves, this means Kempharm must meet expensive post-marketing commitments. But, if there's no abuse-deterrence label, it won't sell, according to Kempharm, so in this case approval may not even be preferable.
Almost certain it is procedural. The federal regs say that without a label the FDA approves, it has to issue a CRL.
We are not going to be waiting very long for this meeting. It takes about 2 months... 1 month to prepare documents and one month to schedule. CRL only related to labels imo, nothing else.