Fresenius conference call notes on Seeking Alpha (YESTERDAY)...Chairman responding to question regarding Omontys status...BOTTOM LINE, Takeda, Fresenius and FDA have come together to move to testing...Clearly the Mexican Standoff between Takeda and Fresenius has taken a benevolent development, probably to help Fresenius figure out how to save some face (SKIN). But the GREAT NEWS HERE is that it looks like they're poised to move forward TOGETHER. READ Seeking Alphas Fresenius Conference Call Transcript (Page 7) to find the following from Fresenius CHAiRMAN !!! Excerpt follows:
Michael, on OMONTYS, your timing's impeccable. What I can tell you is that Takeda has been working with FDA and they are just almost at the point of getting agreement with FDA on a study that will be done in our clinics. It is a DNA type of study where they're going to be trying to understand what could potentially be within the individual that had the reactions, is there something we can learn and understand there? So it's a fairly scientific approach to what we're trying to do. But they continue to work and be very active in understanding what went wrong. So that is an update for you. And as I say, we'll be participating in that study. And I don't know how long it will take, I'll have to talk to the medical guys and see what they think it will take in terms of timing and evaluation of the data, things of that nature. But you should know that they have not stopped, they are continuing to work in trying to understand how they can make this better understood, if you will.
Hardly toast. Just as predicted. O will not come back to the commercial market without a huge, new expensive study. That will take time and O's return will depend upon its results. Good news for Fresenius. Not good news for O's return to market which AFFY says must be SOON for it to survive. Recall, the NY Times article of Feb 24, 2013, shortly after O's recall:
Dr. Daniel W. Coyne, a kidney specialist at Washington University in St. Louis, said that unless the problem was because of contamination, “this could easily lead to withdrawal of drug approval.” He said that “two in 10,000 deaths on first exposure is unacceptable, compared to nothing like this” with Epogen.
Dr. Ajay K. Singh, a kidney specialist at Brigham and Women’s Hospital in Boston, said that the recall should result in “minimal disruption” because centers could use Epogen or another Amgen drug, Aranesp. But he said it might be hard for Affymax and Takeda, which is based in Osaka, to show the safety of their drug without a huge study.
Your CROCKS OF SHEET STILL BOGGLE THE IMAGINATION...And it is clear that EVERYONE HERE except your cohorts have your number...I dub you the CONTORTIONIST CONMAN because I have never seen anyone offer up such a preponderence of twisted facts and logic in my life.
Good luck trying to spin your way out of this...The only way out is for you to cover...Which you said you did AND THEN SHORTED AGAIN...At what, $1.00...Now that was a truly favorable trade, eh?
With the exception of QCOR and AFFYMAX I have a very boring portfolio. I took these two on (particularly against the resident whack pack) because they were very interesting story stocks (IMO) that had gotten beaten down far too much. Questcor has been brilliant since last sep (my average PPS is $19.80 less the recent 25 cent dividend). And Affymax finally saw some progressive news today with the comment from Chairman of Fresenius, that they're moving from Post Mortem Investigation into a joint clinical effort with Takeda to further understand Omontys potential reaction.
My portfolio is more heavily weighted toward Pharma, which is the industry I know best, but well diversified with an average age of maturity of holdings of over 5 years (I AM NOT A TRADER).
I looked at KERX several months ago before it took its first good run, looked interesting but not enough for me to get involved.
Thank You, MaxD for your profound insights. And CONGRATS with QCOR !! You won the battle. I am not in QCOR, but occasionally following your continued fight with short bashes. I am in AFFY, and hope the same victory prevails here too. I really appreciate your determination and commitment to dig the facts from the ground. Good Luck to all longs with AFFY !!!
Maybe this testing will be done after O is re-launhed, as a condition of getting FDA buy-in. That makes more sense than FDA requiring that every future O patient be pre-screened by some DNA test that does not even exist. If so I tend to agree with your EOY estimate for re-launch.
NO, I believe the "investigation" was done and over and the result (to help Fresenius, in a back room deal to minimize damage to Fresenius and MAINTAIN THEIR BUSINESS GOING FORWARD...The "mexican standoff" I have been suggesting) is to collaboratively due this final clinical test (and get FDA buy in since they're participating) to restore Omontys. That's the good news...bad news is that this will take just a little while longer, BUT THEY ALREADY KNOW THE RESULTS...THIS IS A SOP IMO!!! With this there is ZERO CHANCE of Affy folding their tent and a great chance to retain Fresenius as a customer...Meaning the buyout will be significantly higher than if Fresenius dropped out. I stand by my $18 to $24 target AND BEFORE EOY...Check my track record over on Questcor where I have nailed the EPS 3 out of the last 4 quarters and BATTLED WITH THE BASH TRASH JUST AS VEHEMENTLY THERE AS HERE!!!
could it be just wrong dosage? ,02% fatality rate or 5 people on 25,000. In fact now 3 with issues of the 5 dead patients. So close to .01% fatality on 25,000. Many drugs have a worse record. Just Affy in the hands of prop desk at merrill, BoA and HF. They shorted to trigger margin calls make money and now go long step by step
NOT a clinician, but the mere fact that the FDA, Fresenius and Takeda have come together to advance this work is great news. It means that they're trying to delicately help F save face and maintain their on-going business opportunity, which pushes buyout price to the high end ($18 to 24 IMO)...The bad news is that there's a little more work to be done so patiences is still required.
Will be very interesting what Takeda says in their conference call later today!!!