FDA Mission StatementFDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation.
No where does it state that they can't change their minds if information comes to hand or details are discovered. Realise also that there is no proof available that they did change their minds.
Look at the ODAC questions. They are well in line with their Mission Statement.
Now look at the answers. They don't solve the questions posed - they explain the reasons for the shortcomings.
Why didn't MSB start another trial or adjust existing (if possible)? They are ok to do another trial now? I reckon they ran roughshod? And I think the admittance of this misstep is difficult/impossible to deal with by the MSB team. Silence is the option that has been taken, IMO.
I am truly amazed that all the questions by shareholders here are directed at everyone and anyone except MSB?
FDA approval was never going to be easy. SI can cry into his bag of money (Ray Romano quote). Oh, pooooor SI!!
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