If the FDA requested additional information / clar
Post# of 153822
(Total Views: 543)
Posted On: 05/13/2020 10:20:08 AM
If the FDA requested additional information / clarification, and NP and team provided that information, it will be difficult for the FDA to come back AGAIN and ask for more information. IMO.
I'm not suggesting they will or won't, however the FDA now has what they have asked for. There is no need to come back and ask NP and team for more.
I agree with you that as a small company with a badass drug, we may be trying to hit a moving target in terms of the FDA. Given BP and the areas Leronlimab can impact, there are billions of dollars at stake, literally. Throw in the trickle down to funding dollars, research, the impact to other companies and colleges with their own trials and funding, college classes, I could go on and on.
If / when Leronlimab gains approval, the impact will be deep in many areas.
Most importantly will be the deep impact Leronlimab has on saving lives and improving / extending life expectancy of those coping with serious health issues.
I'm not suggesting they will or won't, however the FDA now has what they have asked for. There is no need to come back and ask NP and team for more.
I agree with you that as a small company with a badass drug, we may be trying to hit a moving target in terms of the FDA. Given BP and the areas Leronlimab can impact, there are billions of dollars at stake, literally. Throw in the trickle down to funding dollars, research, the impact to other companies and colleges with their own trials and funding, college classes, I could go on and on.
If / when Leronlimab gains approval, the impact will be deep in many areas.
Most importantly will be the deep impact Leronlimab has on saving lives and improving / extending life expectancy of those coping with serious health issues.
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