Thursday, January 12, 2017 2:01:54 PM
Your undertsanding is correct, they must announce and file the manufacturer site before their final approval or risk rejection. so Its just when they decide to announce at this point in my mind.
as for Podras, I'm glad you agree with my logic. It just makes sense. I'm not saying I am right, but It surely is plausible to go down the way I laid out. especially knowing they only filed one IND and Podras was discussed and granted fast track out of it. it then also makes sense as to why they held up filing until they knew Podras was granted or going to be. so they could include in the agreement. and it makes more sense to go after Podras as an NDA-s rather than starting over from scratch.
But I respect those that disagree. I surly can not claim to know for sure. but I can say the way I laid it out would be legal.
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