FDA OK's ABIO's Personalized Med. Diagnostic Test - Good News For AFFY
This is groundbreaking at the Agency, which normally doesn't allow drug companies to pick and choose patients in testing for safety and efficacy.
Takeda is working with Metabolon, a private company, on a retrospective patient registry analysis with Omontys, to see which subset of patients respond adversely (i.e. anaphylactic reaction) to the drug. This is a very detailed, throrough analysis which will take time.
I have looked everywhere to find this info and nothing is coming up. Can you or anybody please attach a link or at least where you got the info from. If this info is valid then I will definitely buy more shares.
A link would be greatly appreciated, could not find any info when searching. Any idea on the timeframe these tests would take? This is definitely the right route to take to get Omontys back on the market. There is no way Takeda would take this route if there was no chance for Omontys.
Number of patients who had this reaction is 116 with 3 fatalities out of 25000 Patients. It is not clear they are trying to analyze all 25000 patients data or just these ones.
I don't think it is going to take that long for them to announce. I would imagine this #$%$ lawsuit trial might be preventing them from announcing anything right now, even though with the way these Guys file SEC reporting, there is no room for any Case against them. On top of it you have the D& O insurance lawyers, who were some of the top notch lawyers appointed by the Insurance industry and they will make sure the case goes no where.