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Posted On: 07/14/2021 11:52:33 AM
Post# of 148878
Pitt on YMB wrote:
"Today after closing or tomorrow we should get info on the 2nd filing part of the BLA and trial starting in Brazil. So don't get discouraged. Also I provided info to Dr Woodcock last night. She replied to me this morning. I applauded her requesting the internal investigation into Biogen's approval from the FDA. I asked her to please consider requesting an investigation into the Leronlimab trial CD/12. I explained the two shots, the half life and efficacy at days 14, 21 and 28. I also discussed the DSMCs lack to suggest increased dosage or patients saying we are on track. I also noted the FDAs letter that said there was no pri/sec end points met and how that applied to P value only and it was not factual. She said she would take my request into review!
So hopefully we may get some questions answered.
Hang tight big things coming. I know now it seems like there's no end in sight on the price drop. But I assure you double digits soon.
Be happy and hold strong. The squeeze is knocking on the door."
i know, you always have to be careful about the truth of what is published here. But, if its right, what he wrote is right, this would be fantastic! So i pass it to this board.
WUM
"Today after closing or tomorrow we should get info on the 2nd filing part of the BLA and trial starting in Brazil. So don't get discouraged. Also I provided info to Dr Woodcock last night. She replied to me this morning. I applauded her requesting the internal investigation into Biogen's approval from the FDA. I asked her to please consider requesting an investigation into the Leronlimab trial CD/12. I explained the two shots, the half life and efficacy at days 14, 21 and 28. I also discussed the DSMCs lack to suggest increased dosage or patients saying we are on track. I also noted the FDAs letter that said there was no pri/sec end points met and how that applied to P value only and it was not factual. She said she would take my request into review!
So hopefully we may get some questions answered.
Hang tight big things coming. I know now it seems like there's no end in sight on the price drop. But I assure you double digits soon.
Be happy and hold strong. The squeeze is knocking on the door."
i know, you always have to be careful about the truth of what is published here. But, if its right, what he wrote is right, this would be fantastic! So i pass it to this board.
WUM
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