this is going to take a while to work out - I am going to wait
there have been several other instances of anaphylaxis associated with dialysis. It is worrisome that it is found in all clinics and from all lots. That just means it will take even longer.
I think it can make it back to market but I am not going in to jump in on day one unless it gets ridiculously cheap. Too many people just jumping in because of the price. I remember how long it took ELN to recover but in that case it was the best drug in a class. This is a drug that can easily be replaced by epogen et al. I am sure there is a rate of anaphylaxis for epo products but good luck finding it.
It is important to recognize that on page 22 of the FDA medical review for OMONTYS they state there has never been a serious allergic or anaphylactic response during all of the clinical trials. I would imagine the clinical trial was definitely not a multi-use bottle with a preservative because it couldn't be blinded - so it must have been single use in the trials? is it different?
At this point I think AFFY needs to come out and cut costs. The sales force is expensive but if they cut the sales force the market could read into that something like "the drug isn't coming back soon". They said they will outline cost cutting in the next few weeks. Things may be clearer after the next conference call.
Without new news I think I will pass until under $2
Anayphylaxis happens ALL the time with protein therapeutics, but it is rarely FATAL. That is the key problem here that will be nearly impossible for AFFY to deal with, especially when EPO has been around many years and given to millions of patients without a single death. Drugs like Tysabri made it back after causing fatal PML, but in that case, there really wasn't an equivalent alternative on the market AND there was a diagnostic test that could prevent PML. In this case, I doubt AFFY will be able to come up with a diagnostic that is predictive of fatal hypersensitivity.