Last week I called both the Affymax and the xstelos numbers leaving contact info but as expected there's been no reply. When I called in December I was asked to put my questions in writing and they would answered. Apparently that was a lie.
There was mention of DNA testing in cooperation with Fresenius and the FDA last year. Did that happen and if so what were the results. Was there any attempt to use AE survivors’ DNA to narrow the search for a root cause?
With Takeda’s decision to abandon the drug and Affymax’s board pursuing liquidation did Fresenius have any interest in obtaining rights to peginesatide? Has the board of directors approached Fresenius towards that end?
Are there any ongoing investigations into Omontys? What is the status of the product liability lawsuits? Can we have the names of the law firms involved and the plaintiffs?
Has the board made the promised changes to prevent insider trading in accordance with the derivative action settlement? Will Affymax and shareholders benefit from the derivative action settlement as claimed by the plaintiff’s counsel or did they just lie to justify their fee to the court?
Did Mr. Couchman object to these settlements or file for exclusion from the classes?
Can we get some sort of report on just what efforts, contacts with prospects for mergers the Brenner Group made during their tenure.
Is there a reasonable explanation as to why no action was taken to remove the anti-takeover impediments which management has documented in all annual reports.
How many 5%+ shareholders are there?
Can you give us a condensed version of the tax benefit preservation plan. How long will it take to see any benefit and for how long it will last for current Affymax shareholders.
Is it true Mr. Couchman’s Xstelos experienced a reverse split followed immediately by a split. Should we expect a similar maneuver with Affymax shares?
Please describe the procedures and deadlines for nominating board members.
Thank you for your attention to these questions. I look forward to hearing from you soon.
Board of Directors
c/o Xstelos Holdings, Inc.
630 Fifth Avenue, Suite 2260
New York, NY 10020
Having read the article “Anaphylaxis and Hypotension after Administration of Peginesatide” in the NEJM, which I found to be very informative, I have some questions concerning how the expansion was handled and Fresenius’ decision to discontinue use of Omontys on Feb.22,2013. The article stated the manufacturer provided site specialists at the initiation of the pilot. Did Affymax and/or Takeda provide specialists at the expansion?
The article also stated Fresenius decided to discontinue use on Feb.22,2013. I have searched SEC and FDA filings and found no mention of Fresenius’ decision until reading this piece in NEJM. Can you tell me how, when and to whom was that decision communicated to at Affymax and/or Takeda? Is there a report on the evaluation of the pilot as was mentioned in the letter sent to Affymax on Feb.13,2013? If so, will it be made available through an SEC filing as was the Feb.14, 2013 SEC filing?
Additionally, did investigators from Takeda interview the Fresenius employees who attended those patients that experienced reactions to Omontys? How extensive was their investigation. Was it for the 3 patients who died of anaphylaxis or for all those with reactions? Were there any incidents where proper procedures were not followed?
This may be due to my lack of experience with the FDA FAERs database but I was unable to extract Epinephrine as a medication administered to Omontys patients. Were all patients given epinephrine at the onset of anaphylaxis? Where can I locate that information in the FAERs data? What proportion of the reports to the FDA were submitted by Affymax, Takeda and how many from Fresenius?