Let's start with the UNAMBIGUITIES:
1. Affymax as an "OPERATING ENTITY" is KAPUTT !!! And this has been well known and documented for a while now.
2. BUT, Affymax's ASSET has ALWAYS BEEN THEIR FINANCIAL RIGHTS (Milestone payments and royalties) from Takeda, which once Omontys is back on the market are QUITE SUBSTANTIAL.
3. The Brenner Group has been hired to manage the company and have placed several people as OFFICERS OF AFFYMAX. As OFFICERS they became legally responsible to act in a fiduciary capacity exclusively for the benefit of THE SHAREHOLDERS and nobody else!!! As such, bankruptcy (as some have claimed they've been hired to accomplish) MUST be the course of last resort!!! NOTE: While Brenner does note that they do support various BK actions on their website, this is not their primary purpose (they're a turnaround company) and certainly NOT when they have taken on OFFICER STATUS versus acting as a consultant.
4. Brenner has been in the process and continues to be in the process of selling off PHYSICAL ASSETS including plant and equipment and real estate including the forthcoming auction scheduled for 6-13. This would NOT be occurring if bankruptcy was imminent.
5. Allergic (anaphylactic) reactions were identified as potential possibilities on first use of Omontys during all the clinical trials (without ANY deaths) and became part of their final submission to the FDA which approved Omontys with all but one member voting against. ALL reactions and specific clinical responses to such reactions were well documented and made available to prescribing physicians and the dialysis clinics. It was THEIR responsibility to read, understand and administer all precautions and responses to known reactions.
6. Takeda has shouldered not just the investigation of the 5 deaths (out of 25000 patients), but all activities with the EMA and FDA working toward a successful identification/fix of cause of those unfortunate reactions.
MORE in REPLY...
Thank you for your insight as always. I agree that BK is not on the table - what are your thoughts on the possibiity of Affy going private and how would that affect retail shareholders. Thank you in advance.
Can I get an AMEN? Your message posts in this thread do a great job with summarizing the facts surrounding AFFY as we know them today. Outstanding job, MAXDAD01...
Sentiment: Strong Buy
Amen! Maxdad does a great job putting the facts together. It's no wonder the shortz hate him and take cheap shots at him. He's raining on their parade, not that anyone would actually listen to that silly lying Godwin.... A blind man can see he is a fraud.
Madmax, Lol, you are too old to be a "quick study" on a complicated case such as Affy. Several things to note, 2 deaths were cv related and happened earlier and did not get reported to shareholders thus, multiple Lawsuits resulted, secondly, the other three deaths did not happen at the same facility, thirdly the allergic reactions were treated immediately by Doctors and the Patients expired any way. You seem to be near senile and windy as a bag of aholes! Lol P.S. the Giants suck, make your 34 year old son move out of your house before you BK him with bad Qcor investing advice! Lol You remind me of my Matrix Intern!!!
wildbill...nice try but I still have all my marbles (I'm under 60) and still get offers all the time to do M&A work for pharma companies after over 30 years at the top of the Pharma M&A game. I don't need the money, but for truly interesting situations I still do consulting and get paid a hell of a lot more than the minimum wage you must be getting as a paid basher :-)
BUT to give your one point of substance where you said "the allergic reactions were treated immediately by Doctors and the Patients expired any way." I find that interesting and have NEVER seen that cited anywhere, so please be kind enough to provide a direct reference to that information !!!
7. All 5 deaths occurred at Fresenius' clinics. ALL in the first 10 days and ALL on first dosage. ALL OTHERS OF THE 25000 TOTAL PATIENTS were NOT fatal, and there was a distribution of known side effects comparable and approximate % to those experienced during the clinical trials.
8. It is NOT in Takeda's interest to allow Affymax to declare bankruptcy because it leads to immediate complications, stretches out all potential options significantly, can easily lead to unintended consequences once in the hands of the courts (including but not limited to Affymax's rights to Omontys going to an organization OTHER THAN Takeda).
9. Given that positive results from the Takeda investigation would lead to significant revenue (almost 100% dropping to the bottom line now that there is very little overhead left at Affymax), there is ABSOLUTELY NO DOWNSIDE for Affymax's creditors to wait to see this through. Should there be an investigation conclusion that leaves Omontys and Affymax AT FAULT (which would mean that it would HAVE TO BE SOMETHING OTHER THAN THE KNOWN ANAPHYLACTIC REACTIONS!!!), then the creditors would be in no worse shape to require a bankruptcy than they are today. NOTE---This is a point that has never been mentioned in anything I have read anywhere!!!
10. Omontys, prior to these events, had a well documented and acknowledged future as a very viable competitor to Amgen's Anemia drugs (which also have had several fatalities) because it has been shown to be every bit as effective, only requires once a month dosing (versus every other day) AND the fatalities have only occurred on first dose. Amgen's fatalities have occurred across the entire life-cycle of patient application.
FEEL FREE TO ADD OTHER CLEARLY KNOWN POINTS THAT ARE PRESENTLY UNAMBIGUOUS.
AMBIGUITIES COVERED IN NEXT REPLY...
AMBIGUITIES (UNKNOWNS AND NOT TOTALLY PREDICTABLE AT THIS POINT) :
1. There is some chance (small, but there) that the cause of these 5 deaths could be something other than previously experienced allergic/anaphylactic reactions. This includes, but is not limited to, unknown interactions with other drugs...exacerbating anaphylactic responses due to such interactions that exceeded known responses...other patient biologics or biochemical reactions NOT encountered during the clinical trials (NOTE: There were different levels of allergic reactions between those who were on or NOT ON dialysis during the clinical trials). Just as possible are events outside the scope of Omontys reactions or having absolutely nothing to do with Omontys though these are highly unlikely given the population (all first time users...all in the first week or so of roll-out to dialysis clinics). The autopsies, post autopsy mortality/morbidity analyses and the current investigation by Takeda will provide the necessary scientific findings required to render the appropriate conclusions and next steps. BUT needless to say, while I may believe that these results and conclusions are already known by Takeda, they have yet to be made public and therefor ARE still AMBIGUOUS.
2. While it is highly unlikely that Affymax will find itself requiring a bankruptcy and equally unlikely that Takeda would do anything other than help to prevent it, NONE OF US (Longs/Shorts, bulls/bears, bashers or cheerleaders) have access to exactly where things stand with any of the parties various investigations, analyses or, most significantly, NEGOTIATIONS for where they intend to take Omontys either clinically or financially. NONE OF US KNOW ANYTHING FOR CERTAIN on these behind the scenes activities. SO ANYONE (including myself) who authors something here claiming to KNOW WITH CERTAINTY THE EXACT OUTCOME of these events are either lying or have insider information the disclosure of which is strictly prohibited!