I have some modest experience with similar circums
Post# of 153802
(Total Views: 523)
Posted On: 05/22/2021 11:45:27 AM
I have some modest experience with similar circumstances in another industry and bureaucracy. That does not mean all things translate. IMO a fight between a small pre rev OTC bio and the FDA isn't a fight, it's a slaughter, a slaughter that in our case already appears to have begun. Input from pre rev shareholders is simply irritating noise for both the pre rev and the FDA. The louder the noise the more irritating for both entities.
The above said, IMO, a fight between the FDA and a select congressional/senate committee isn't a fight it's a slaughter. Share holders will IMO have little influence on house/senate members outside of polite responses that go no where worthwhile. The $ motivation, secondary or primary, is just too obvious.
Well informed MDs making compelling cases in language clearly understandable to those on the committee (or other influential politicians/bureaucrats) who are in a position to care, and actually do care, is IMO the correct weapon. Compelling case presentations that target the specific mission of the individual the MDs are communicating with in the select committee is critical. I think Drs. Misui, JL, and Harish are all quite capable of delivering very sound presentations. The latter two more so because they have no money in the game.
I think any scorched earth approach, no matter how satisfying we think it might feel, is a bad idea. It would be nice if all parties could collect solid wins. Perhaps the FDA could use the new data release this week to justify a more helpful response.
In short, if the committee can be convinced to a significant degree that LL is a game changer, unaffected by the up coming variants, there should be a way for all parties to win. The shrill of shareholders is just obnoxious noise.
All IMO, of course.
The above said, IMO, a fight between the FDA and a select congressional/senate committee isn't a fight it's a slaughter. Share holders will IMO have little influence on house/senate members outside of polite responses that go no where worthwhile. The $ motivation, secondary or primary, is just too obvious.
Well informed MDs making compelling cases in language clearly understandable to those on the committee (or other influential politicians/bureaucrats) who are in a position to care, and actually do care, is IMO the correct weapon. Compelling case presentations that target the specific mission of the individual the MDs are communicating with in the select committee is critical. I think Drs. Misui, JL, and Harish are all quite capable of delivering very sound presentations. The latter two more so because they have no money in the game.
I think any scorched earth approach, no matter how satisfying we think it might feel, is a bad idea. It would be nice if all parties could collect solid wins. Perhaps the FDA could use the new data release this week to justify a more helpful response.
In short, if the committee can be convinced to a significant degree that LL is a game changer, unaffected by the up coming variants, there should be a way for all parties to win. The shrill of shareholders is just obnoxious noise.
All IMO, of course.
(12)
(1)