Since you apparently think of yourself as the only one who has a clue about how things work with bio-techs, consider what would happen to the stock price if they had come out with a PR today that said that they were NOT going to file for an MAA with the EMA.
KERX cannot get to full valuation until every box is checked, including the MAA filing.
The bio sell off is in its third day, and seems to be losing steam. Look at ACAD, ALXN and IDRA. I think it will be KERXs turn later today, or by tomorrow morning.
As soon as an MAA is filed with the EMA, a decision must be made within 210 days. So a decision could be rendered as early as mid October. If the EMA has any questions about the application, the 210 day clock is stopped until its questions are answered. Since there is a wealth of clinical data from Japan and the US for both dialysis and predialysis, any delays are likely to be short. I expect a decision by the end of the year.
I believe evidence of damage is why QCOR came out with their 8-K filing. I also believe the reason they came out so quickly with the 8-K is to mitigate the damage before it got worse. Bailey clearly made a very public and legal threat to those who were tarnishing Questcor's reputation. I don't believe he would have done that had he no basis for doing so.
Corporations have standing, and may sue for defamation when false statements are made about their businesses or reputations .An actionable statement must be untrue, it must be made in writing or verbally to a third person (publication fits this criteria), and it must cause the corporation damage.
In Monday's 8-K filing, CEO Bailey said, "Questcor believes that the entities involved in the short attack have been actively engaged in promoting activities solely focused on tarnishing Questcor’s reputation and distracting investors from the Company’s investment fundamentals. Questcor has discussed the short attack with the Division of Enforcement of the Securities and Exchange Commission, or SEC, and the Company continues to evaluate various options to protect the Company’s shareholders as well as the reputation of Questcor and its employees"
In order to provel libel in the United States, it must be proved that the statement was false, caused harm, and was made without adequate research into the truthfulness of the statement. For public entitties or persons, it must also be proved that the statement was made with the intent to do harm or with reckless disregard for the truth.
Ya suppose the short sellers research report fits the above critieria, shortie?
Tortious interference is a common law tort allowing a claim for damages against a defendant who wrongfully interferes with the plaintiff's contractual or business relationships.
Would it take only a single example of one patient willing to testify in court that they discontinued using ACTHAR because of the short seller's libelous research report that it did not contain the active pharmaceutical ingredient? Or may be a pharmacy that refused to dispense or an insurance company that refused to pay until the matter is cleared up?
Whaddya say shortie? Who's your daddy now?
You are correct on this, and is the basis for my flippant remark yesterday that the FDA might be "reviewing" the short seller's lab report by Thanksgiving, if ever.
If QCOR's manufacturer was not cGMP compliant, or ACTHAR lots were not manufactured according to their FDA label, it would have come out in the medical community years ago.
QCOR has always had the power to fight back, so why did it choose this particular short attack to forcibly and publicly respond to? Always before, QCOR would say little and essentially allowed the shorts weeks and months to knock the price down. Could it be that there is a pending announcement of a strategic decision or tax inversion that requires a fairer valuation of the stock prior to it being announced? And by pending, I mean WAY before the Q1 CC at the end of April, otherwise why put a stop to the attack now, and just let the normal runup in price leading into the CC do the job?
Yesterday's release of the 8-k was a black swan event for the shorts, and increased the risk that more are on the way. Maybe that is why Anidy boy and his thugs are "stepping aside". No more easy money on QCOR. They are going to have to earn it the old fashion way, like mugging helpless old ladies on the street for beer and cigarette money.
In the last two days, short sellers have invested may be two million shares or so at an average of $68, or $136 million based upon their lab findings that "appears to be consistent with what is specified on the FDA-approved Acthar package insert. "
That is as stupid as claiming there is a massive risk of the FDA pulling aspirin off the market because independent lab results show it contains acetylsalicyclic acid.
This stock was pushing past 80 before this nonsense began, Q1 earnings will be out in two months, and the fundamentals are just getting better.
Best of all, it appears the "short sellers" referred to in today's 8K are now in QCORs cross hairs. Turnabout is fair play.
Keep executing, stick to your knitting, don't negotiate with terrorists, blah blah
At some point, don't these non stop back alley muggings become personal?
All the stakeholder's in this company, including patients, are watching the value of this company evaporate.
Even a buyout, which would shut the shorts up for good, would proceed from a share price base that is about half of what it should be.
Execution has to incorporate pro active strategies to counter actions by those who wish destruction upon this company, or they win and everyone else loses.
Other pertinent questions might be is how old are the vials? Are they past the expiration date? Were the vials opened and for how long? Were they contaminated? How were they transported and under what conditions?
What is the chain of custody to insure the vials came directly off of the production line, not tampered with, and went directly to the lab? Were the vials randomly selected from different batch productions over an extended period of time? No? Then how can the results be statistically valid? Is this a nationally certified lab qualified to perform these specific kind of tests, or is it just some titration and test tubes set up over someone's back yard garage?
Citron is not a research medical facility, but a financial web site run by a convicted felon, and will not answer these kinds of questions.
We all know the drill.
Raven and the other short magpies screech to each other, cite each other, quote unnamed sources, threaten to contact the FDA, FBI, CIA and Homeland Security and warn of impending asteroid impacts until small time retail in this stock is squeezed out.
They have no effect on the long term investors, and provide great entry points for swing traders. I expect we will see a week or two of this nonsense.