Yes I know. My point is that you were saying it is about P2s and P3s, and I said no it is not. And you agreed with me that it is not but then said to deal with it.
Also, I don't have moose breath. I believe you are smelling your own breath after accidentally mating with a moose.
Well, if we are to talk about the law,
1) Orphan drug and fast track designation has nothing to do with data in a trial. The FDA does not have access to this data and it is they who determine fast track and orphan drug designation.
2) Insider trades must be declared well in advance of the trades taking place (months or years), usually with a purchase or sales plan submitted to the SEC.
See CMRX. The only reason their trial failed, wiping out 2B of market cap, is because 36% of doctors did not follow the SMMP (safety monitoring and management plan) procedure, even with a DSMB there to advise the company. Incompetent management failed ensuring a very simple step of preventing the drug from being taken during bouts of diarrhea and destroyed the stock price.
Don't change the subject. You said it was about P2s and P3s and now it is about predicting when the corrupt FDA will act on its corruption.
I don't agree.
"However, the FDA did not provide clarity on a regulatory pathway for an LDL-C lowering indication in the U.S. in statin intolerant patients at this time."
In a different market environment, this would be viewed as a non-event. The take-down of Visium Asset Management proves that at least some in the FDA are 100% corrupt. The market is very corrupt as well. So, there you have it.
The text of the PR indicates that there might be a very small chance for something here so I agree it is short covering that is causing the price to even stay at these levels.
No. They can't communicate the abuse-resistant properties without a label. Anyway, we don't know the details.
Interesting point. Did they have enough money to reach the finish line when they did the 25 cent offering?
You might also wonder why that Thursday when it was at $7.30 when the company stated that it did not (yet?) receive an abuse-deterrent label from the FDA the price actually was up most of the day, compared to essentially the same news the next week when it had already dropped $3. Too much retail was trading this stock for the potential that the company would get the abuse-deterrent label in June. But, they weren't going to market this anyway until next year.
I think not enough people did their DD as is usually the case and dumped on the big-bad "CRL" text. Plus you have shorts seeing that and pummeling the very low-float stock. Plus, that set off the retail stops and it just kept going down until most nervous retail traders were flushed out, which was hopefully a few days ago.
No one has Kempharm's technology, either. Check the 511 rat data -- no deaths on ANY dose. This could completely transform the oral overdose problem from one that is by far the #1 killer to a mild irritant. POC data coming within the next 6 business days.
Kempharm was slaughtered from 17 to 4 based on (what I still believe to be a delay in) just one product. Pipelines or platforms aren't valued much these days by the market.