I agree with your comments.
All these comments about the ‘incorrect’ decision are predicated upon the belief that the FDA: did not understand the product; are corrupt; Donny Trump had something to do with it/or should now have something to do with it; big pharma are involved; all msb need to do is “go upstairs” or go legal; or some how because msb is not American it wasn’t approved. Well, phewy.
The issue is msb did not have the evidence. Msb ought to have been concerned because of the FDA meeting. If the product does work and is safe, then it is on msb for its failure to gain approval. If the product does not work or is unsafe, then FDA’s decision is correct.
MSB to dispute FDA finding in Type A meeting, page-180
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