Though Takeda recalled the Drug even though those who were not affected (who didn't have any adverse reaction) were allowed to continue with the drug. Why did they do that?
Is it a very calculated move? I presume so.
(a) They could dismantle useless AFFY setup and sent packing Orwin gang which was the biggest hurdle for them.
(b) Secondly even Frensius did pause enrolling new patients, however they intend to continue with the Drug for those who did not have issues.
The "PAUSING" of enrolling new folks has caused a huge fury at Takeda HQ and then they decided to recall the Drug in total and screw them big time.
First of all it is an approved drug which has gone thru lots of research and trials. Why in the world Frensius needs to do the study on their own and absolutely no need for them to do that sort of study or analysis and then do a pilot rollout only to stop after it is successfully administered for 18800 Individual patients. That is where the problem lies here.
If there is anything they need to report and continue administering the Drug and enrolling new patients and constantly improving the administrative protocols as and when the problems arise, since all ESA's have known issues and everyone of them has extreme Black box warnings!
Being the largest provider of Dialysis services in their country and their collusion with AMGN has caused huge heartburn to Takeda.
The only way forward would be to force (Frensius) them to accept the Drug and provide it as an alternative to Epogen.
Even the death of the patients looks to me is stage managed to prove their case. Having known the issues prevalent in the administration of ESAs it is absolutely impossible for Frensius to make an error of some sort, rather it looks they ensured to proliferate negativity about this drug by causing this extreme situation.
None of the Other dialysis centers encountered any issues, these allergic reactions were controlled as specified.
It seems to me what sort of action FDA is going to do to force FMS to allow the drug to be administered as specified rather than working on behalf of AMGN and undermining the competition in this space.
Takeda will resolve the issue and the product will hit the market, it is just Frensius issue due to their close proxmity to AMGN! It is the work of FDA and competition bureau to looks into this issue and resolve.
The drug works, efficacy is proven, lifestyle change, ease of administration, easy to make and administer and low cost.