The EIND had nothing to do with the m2m trial. T
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Posted On: 01/02/2021 7:01:52 PM
Re: craigakess #70955
The EIND had nothing to do with the m2m trial. To my knowledge the only response from the FDA regarding our EIND, was to give us a phase three trial, after they had previously refused to.
I think you can make an inference there as to what they thought.
This is my opinion, but if you only look at what the doctors say, and the actions of the FDA (giving us a phase 3 trial, which basically catapulted us into the lead), the DSMC recommendation to continue. The M2M stat sig results, the reduction in SAE. They all point to the same thing. And it's not even that hard to see. Vyrologix clearly works.
I challenge anyone on this board to show me a single piece of evident to the contrary.
I think you can make an inference there as to what they thought.
This is my opinion, but if you only look at what the doctors say, and the actions of the FDA (giving us a phase 3 trial, which basically catapulted us into the lead), the DSMC recommendation to continue. The M2M stat sig results, the reduction in SAE. They all point to the same thing. And it's not even that hard to see. Vyrologix clearly works.
I challenge anyone on this board to show me a single piece of evident to the contrary.
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