I share your respect for Caplan,
He was wrong then and he’s since passed away. He knew what he was talking about and his understanding would outstrip yours.
I don't think either or he or I would say to you that science is about the size of one's ego - I think he and I would say to you (or to anyone doing comparisons of expertise)- think for yourself - do the science reasoning yourself.
The FDA now agree with him.
The Marks/Verdun version of the FDA have granted MSB a BLA - that is a fact.
Why they did - that is a matter if conjecture for me - the science stuff really isn't much.
Pfeifer said he thought this a political decision not scientific one. That is also what I think.
Pfeifers said re the FDA - it was about saving face (actually this saving face stuff he and I have misunderstood each other about before - actually he thought I was referring to him when I wasn't when I said there was no need to save face (I meant the FDA hadn't lost any with the CRLs - they'd done the right thing).
Now I think its not whether the FDA under Marks and Verdun have saved face for me - its about whether or not weak politic types have sold out their souls and their duty if I could put it that way.
Please understand I am not asserting that I know for sure that Marks and Verdun did the wrong thing (on the science evaluation - not dealing with the potency assay and confounding in the GVHD001 trial transparently (perhaps they've addressed it behind the scences) because they are weak - but I am saying that that is a working hypotheis of mine - that is I'm thinking its possible Verdun and Marks failed in their duty because they are weak characters that need the approval of others and want to be a part of something big even if the something big isn't ready.
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3 | 26451 | 0.155 |
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Price($) | Vol. | No. |
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0.175 | 14285 | 1 |
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