I think there's also the possibility of contempt of congress, with the commissioner being arrested by the sergeant of arms and called before the house or senate.
Every medical institution operates under a set of policies and procedures that are managed by a governing body, eg an infection control committee. Every time a new treatment modality or equipment is brought in the policies and procedures must be created and updated, and staff needs to be trained. The production of blood products is a process involving many carefully controlled steps. Validation is the implementation of the new process that has been modified as a result of introducing intercept. An outcome standard is adopted and quality control processes are altered to assure the results are as expected. The reason is that any change in the process of producing blood products has the potential to introduce errors. How long this takes depends on the institution and the urgency. I would expect some q/a is called for in parallel to make sure the process works as expected before cutover.
The first thing is to execute; finish up the P3 and file NDA. There's also a cap rate requirement for nasdaq so the stock needs to get pumped up. A reverse split doesn't boost the cap rate by itself. Getting shorts to cover would go a long way. Another order from BARDA to make up for the portion given to chimerix would do the trick. It's a chicken and egg proposition gotta have good news to raise capital and gotta raise capital to remain intact. The wild card is Ron Perelman. It is entirely conceivable that he would loan money to pay the judgement.
capitulation. Why would the share price climb on huge volume with a negative adcom? The FDA is captured. Somebody knows this will get approved. It was the last chance to cover.
You are mistaking the outcome of a contentious law suit for management. How would you have managed things better, wise guy? You were here using a different alias with the same agenda back in the days of Cindy, Moskowchess, and rivalmoney. Why don't you grow up and accept the fact that you made a mistake (like the rest of us) and move on. Blaming somebody for your bad judgement is infantile.
Careful trying to catch a bottom. Cost me bigtime the last time it tanked. And the selloff was on way less tangible evidence of declining sales and supply chain shortages. This can go way lower than you can imagine, like 50 bucks a share. The problem is that AAPL captures 90% of the revenue on cell phones while its competitor, samsung captures 90% of the unit sales. Anything that cuts the huge margins will kill it.
Shouldn't take long to do the stats on AE and PK. They are doing rolling submissions so the data should go to the FDA at the same time they file the NDA package. With a little grease applied through political connections it should move fast. "We use the power of persuasion first. If it doesn't work, we try the persuasion of power” Andy Stern.
The price has reacted like there was leaked information coming out of the FDA. I'm thinking today's volume was some serious covering/reversing based on that same inside information. Perfect setup to cover in the face of stinging rejection.
AFAIK they are all still walking. Are any on the verge of losing ambulation? When will the next readout on their 6 mwt be disclosed? These subjects were chosen based on the belief that they were on the shoulder of the ambulation curve and would rapidly lose the ability to walk if left untreated. This emperical outcome is really all that matters. The rest is hair-splitting.