IMO here is why the run-up:
1) Europe FDA decision (bad or good) at any time (my money is on Monday or Tuesday morning (12am-7am)
2) This past week Fresenius Medical Center have come under a huge negative wave of press and pressure from the FDA. Supposedly, Fresenius reported to the FDA that Omontys killed five people. Two deaths were immediately determined not to be Omontys. Now I believe Takeda will fire back at Fresenius when they report back to the FDA. This is event is very close to happening.
3) We may find out that Affy didn't pay the entire bill to terminate the Nektar manufacturing agreements. Nektar's agreement included a high single digit royalty. Termination benefits Takeda here.
Omontys coming back to market is a bigger catalyst then a buyout. Takeda could buy Affy in a matter of seconds but Takeda has already benefited greatly by squeezing the royalties and acquiring Japan market. I believe if a buy out happens that it will be an offer from a private equity firm that is willing to gamble here.
As for delisting: If it happens it happens but remember getting Omontys back on track is the only event that matters. Affy's BOD have to be very careful how they present themselves and the situation. If they said they would fight the Nasdaq ruling the speculators would be all over this and they don't want to do this with all the lawsuits. But ask yourself did you see a disclaimer on either 8k about any potential BK?
This could still go bad on Monday but...I doubled down this week because of the Europe Decision and especially because FRESENIUS is about be blown up and the remaining three deaths... well lets just say Takeda plays pin the tail on the donkey very soon.
Shell company???Maybe but not many shells out there holding a potential billion dollar drug with Millions in milestones and royalties. Holding company is more like it.
to bad Orwin is still on the BOD and he better NOT come out with the typical gloom and doom statements because affy cant afford to be beaten down again. I am going to toss the 100k I pulled out Friday back in Tuesday and take a #$%$ gamble because the upside is well worth it.
Yes the Fresenius fiasco looks good for Omontys but apart from the deaths there were more hypersensitive reactions post approval than in the clinical trials that also need to be understood in order to be minimized and hopefully Takeda's investigation brings this insight - the source could be one and the same.
Again majority of these reports of reactions (and all of the deaths) come from Fresenius since this where Omontys was under a pilot program. This being the same medical center that Amgen recently got in trouble for kick backs.
Even prior to the Omonty pilot program Fresenius had major problems.
"Fresenius issued an internal memo to their own clinics in November 2011, indicating that an internal review of patients treated at 667 Fresenius dialysis clinics in 2010 and found at least 941 instances where individuals suffered cardiac arrest during dialysis treatment. "
Fresenius can't play the blame game with AMGEN due to the monetary impact. Affy became a perfect target. So I'm not sure that the information on the potential reactions will be deemed accurate. All the drugs in this sector have reactions but right now its the remaining three deaths that matter most to clear up.
Human error in the administration of Omonty is key but so to is the treatment of the actual reaction itself.