Hi - The Brenner Group is a restructuring firm offering a variety of management services who is doing a very good job restructuring Affymax by working with the banks, suppliers and preserving cash. Granted, not all of its clients have the same mission, but Thankfully we are Lucky enough to have the #1 Japanese pharma company as a Strong influential partner with much to gain upon a reinstatement of OMONTYS with a new label. They are shareholder friendly too and an honorable company. There is a lot at stake for them and Affy, so don't be fooled by the bashers here or on any board for that matter.
Everyone has a HUGE vested interest here or this would already be over, and its not. This is why I'm in as a shareholder and I have added to my position. When more risk is eliminated and hurdles are overcome, the stock should be a whole lot higher, not $1.60, but many times higher.
If this company holds too much risk for you and you still want to be invested in Biotech stocks, take a look at IBB where my family's trust has been invested since late 2011 in the $90's.
Other good biotech stocks right now include: REGN, PCYC, QCOR, SGEN, VVUS, others..... Chart permitting.
Watch the charts for entry and exit signs if you follow technical indicators.
Ok, have a great day everyone.
Part1 .......of a drug that should return vs the nay sayers.....
February 13, 2013
We are writing to provide an interim update on the status of our pilot to assess the use of OMONTYS® in the FMCNA dialysis facilities. The purpose of the commercial pilot is to determine the role of OMONTYS® as an alternative Erythropoiesis Stimulating Agent (ESA) on the FMCNA Formulary. The assessment includes efficacy, safety and logistics related to this agent that was approved for use by the Food and Drug Administration at the end of March 2012.
We will now pause expansion of the pilot that began in late July 2012. We have accumulated experience in more than 56,600 administrations in over 18,000 unique patients. Two months into the FMCNA pilot program, the FDA released revised product information that added language similar to the prescribing information for EPOGEN® concerning the risk for allergic reactions, which we communicated to you in November 2012. To date, we have seen infrequent allergic reactions in our patient population receiving their first dose of OMONTYS®. Most of these reactions have been mild, but a small number have been serious. The rate of allergic reactions has been on the order of 1:1000 patients receiving a first dose of OMONTYS®. The vast majority of patients who are receiving the medication on an ongoing monthly basis are tolerating it well.
More....See Part 2
Part 2 ........
We are now working to analyze the full set of efficacy and safety profile information and feel that the current scale of our experience with use of the drug is adequate to complete this analysis. These results will be presented to our Corporate Medical Advisory Board with follow up reporting to our medical staff. In the meantime, this communication is to inform you of our confirmation of the adjusted prescribing information and the finding that such allergic reactions can occur in patients receiving the first dose of the drug. For patients on OMONTYS®, we recommend continued use of the agent as it has been providing effective anemia management. We plan to pause the rollout to additional facilities and patients at this time until the analyses are complete and reported to our medical staff. As many of you have become quite comfortable with the medication, physicians and facilities that have been using OMONTYS® who wish to continue prescribing it for new patients may choose to do so.
As we complete the analysis in the next week or two we plan to provide an update on the pilot experience and any future recommendations. I thank you for your participation in determining best protocols and practices around the use of OMONTYS® and we will update you with the analysis of our experience once complete.
With best regards,
Franklin W. Maddux, MD, FACP
Chief Medical Officer
Executive VP For Clinical and Scientific Affairs
Fresenius Medical Care North America
Jeffrey L. Hymes, MD
Associate Chief Medical Officer
Fresenius Medical Care North America
If you are a serious buy and hold AFFY long, do yourself a favor and go to the Brenner Group website and look at the PDF detailing their success stories. All nine of them show an ending that is not kind to stock holders, as officers get their termination compensation, suppliers and landlords are paid, assets are sold off and what remains, very little if anything, goes to shareholders and the taxman. If you are a trader who knows what Exp, Max and WS is all about, then you already know what your are doing. Take your profits when present, but do not be caught left holding an empty AFFY bag.