Aranesp/Epogen has the active ingredient darbepoetin alfa. It is used to treat anemia and muscular dystrophy. Commonly reported side effects of Aranesp include anemia, pain, aplasia pure red cell, fatigue, and hemoglobin decrease. Aranesp differs from endogenous erythropoietin (EPO) by containing two more N-linked oligosaccharide chains. It is an erythropoiesis-stimulating 165-amino acid protein.
Recently it was reported to the FDA, that patients under Aranesp have anaphylaxis incidents of 0.48%, more than double compared to those injected with Omontys's 0.2%.
The only difference between the two drugs is that AMGEN, who markets Aranesp, clearly outlines in their label HOW to treat anaphylaxis and the symptoms associated with it. AFFYMAX did not outline the proper treatment guidelines for OMONTYS and prior to the recall had no incidences of mortality associated with the use of OMONTYS due to allergic reactions.
Yahoo does not allow links in posts and occasionally deletes my posts altogether, but if you search the FDA website, look for the clinician information. Its a long read, approx 100 pages or so but there is anaphylaxis statistics, as i have provided above.
Like i have said in the past, i can not predict the future; however, I am anticipating a positive update within the next month.
1. AFFY has cleaned out its balance sheet,
2. AFFY has progressed rapidly with restructuring by significantly laying off majority of its workforce,
3. TAKEDA has taken full responsibility of the recall for OMONTYS
4. Collaboration with the FDA has been an ongoing process, since the recall
5. AMGEN is obviously threatened as it chose to do pharmacy kickbacks in order to promote their drug. AMGEN pain 24.9 million dollars to bury the allegations.
6. TAKEDA will buy out AFFY over AMGEN because TAKEDA wants the right to a drug with a $3-6 billion dollar a year potential.
7. I've been in medicine a long time and i did put my money where my mouth is. A drug that was FDA approved, cost over a billion dollars and 15 years worth of research will not be squandered.
I will either fall with all of the longs, highly unlikely or I will join in celebration, all of those who had the nerves of steel to hold on during this most stressful time.
In any event, please don't risk money you can't afford to lose. AFFY is still a very high risk stock and is a potential all or nothing at this point. GL to all my fellow longs
Keep up the good and honest predictions !!! Every time you post a message, it makes make believe more on holding on to AFFY shares until Affymax is bought by TAKEDA, even though it is a very high risk investment.
Raj - i am laughing here. Naturally, God Fraud is mute here! He is speeches! Why? He is a big mouth when he cuts and pastes his propaganda on this board, but to actually "think" he is deaf, dumb, and blind.
I hope we do celebrate. I am in one of the following locations where i own homes: Berkeley, CA, Port Townsend, WA - or St Paul, MN. Raj - where are you located??
Good Luck Longs - i think the tide will turn for us...
I must say that it's a very interesting post and probably the main reason why they initiated the recall. By now Takeda has an idea about the root cause of those death and will address them via the recall SOP. Takeda would never sign a licencing deal with Affy if they didn't believe that Omontys won't be back. They are probably working back and forth with the FDA for another REMS post reintroduction of Omontys.I would not exclude the possibility of a buyout from either Takeda or Amgen who has a good working relationship with Takeda and much more experience with this type of drug adverse events. It's a win-win for both cies. For the price it's up to Affy majors holders. We should have an update of the ongoing recall pretty soon.