It is hardly fair to say AFFY is a binary event play. There are many stars to align before LaffyStock becomes an investment. Sure there would be a "pop" if it was suddenly announced that AFFY returns, but:
1. Takeda/AFFY apparently have no idea what is the root cause of O's allergic reactions/patient deaths;
2. Even should Takeda ever determine the root cause, Takeda must still decide whether or not O has been so damaged that it is no longer commercially viable considering its damaged reputation, the long established safety profiles of industry standard ESAs, and its one advantage, once a month dosing, being lost to Roche's Mircera.
3. Even with the root cause established, there is no assurance that Takeda could come up with a cost effective mitigation plan that would allow the FDA to reauthorize O's return to market.
4. The recall has called into question the clinical studies results that the FDA relied upon in approving O in the first place. The EMA, in its provisional opinion issued upon Takeda's withdrawal of O's EMA, explained that it would not have approved O anyway because its risks of patient harm outweighed its benefits and that the studies Takeda filed in support of O's MAA "might not be reliable".
5. Experts have previously stated that, in their opinion, the FDA might not allow O's return unless its safety is reaffirmed by costly and time consuming new clinical studies.
6. AFFY has little cash. AFFY's own SEC documents say cash is projected to run out by June 2014.
7. AFFY has a crushing litigation burden, namely a significant securities fraud class action litigation, shareholder derivative claims and anticipated products liabilities claims.
8. The Brenner Group, who specializes in managing companies in preparation for bankruptcy liquidation/reorganization, has publicly announced that there can be no assurance that AFFY will not file for bankruptcy protection.
ASK YOURSELF, DOES THIS SOUND LIKE A "BINARY EVENT" PLAY?
1) "blah blah.. apparently.." Apparently youre just speculating since you have no friggin clue whats going on inside these companies.
2) If Mircera has made Omonty's obsolete, Takeda would have already pulled the plug on it.
3) Wild a_s speculation.
4) "..called into question.." (not invalidated) "...might not..". All wild a_s speculative statements with no teeth.
5) "..might not.." More wild a_s speculation. No teeth.
6) If it were going to ACTUALLY run out that soon, shorts would not be covering under $1 as they have been for a long time.
7) Litigation will take years and AFFY will iether have Omonty's returned to the market well before then or Omontys will go away (binary event scenario).
8) "can be no assurance". Boiler plate legal crappolla. There is never any guarantee of ANYTHING in the future when a corporate entity makes forward looking statements.
and yes, it still sounds EXACTLY like a binary even play.
Good points GWP. At this point (3.5 years after O-induced deaths killed off Affy's chances at more lucrative non-dialysis approval), it is almost laughable to think that T and or A would suddenly discover the root cause. I mean, is it ever the case where any company (certainly one being sued) would come forward and say, "We have found the root cause. O is chemically made up in such a way that some people will have a shock from it and, unless somehow heroically saved, they will die." In other words, isn't it clear that, by their silence, T&A actually understand very well the 'root cause'. It is clear to me that O is the root cause and that there will never be any magical answer otherwise, only Japanese crickets.
I have to believe that a large majority of posters/pumpers here understand this to be true. Their posts, however, are rather convincing that they do not believe this and that they really are as preposterous as their tragic posts indicate.
There's still the unanswered questions of how many CKD patients on Dialysis have died since Omontys has been recalled? Our short boys refuse to answer. They have gone to great lengths to vilify Omontys as the cause of very sick patients dying without establishing the continuing incidence of adverse events for this patient population. These two shorts who have profited greatly from the deaths and hope to drive the company to bankruptcy. One of these characters has admitted repeatedly of finding this to be entertaining. Most shorts have covered their position moving the short interest for a high of 18 million shares to under 5 million shares. I'm guessing those are folks who don't have insider information. One modest short says he's made over 6 figures but if we are to believe his posts its more than a million. Pretty good reason to post ad infinitum.