That could very well be the case, especially given
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Posted On: 02/08/2020 12:16:21 PM
That could very well be the case, especially given the recent success in cancer (would justify why the FDA changed the requirement from previous 100 patients safety data). Asking for all the safety data the can now for the initial approval IMO bodes well for BTD and AA and the FDA May just be covering their ass. Given the recent discussions I can see this as making the most sense for now asking for additional safety data for combo.
The recent basket trial starting at 350 mg may also play into this. If proven to be as successful at 525 mg and 700 mg (unlikely) maybe they will even go with a lower dose given the more safety data for that dose. Possibly even using receptor occupancy test (ROT) to verify or validate dose levels by density? This seems to have disappeared from discussions, but seems keys to personalized therapeutic medicine and even more important if both HIV and cancer get approved around mid-2020 and commercial inventory is limited.
The recent basket trial starting at 350 mg may also play into this. If proven to be as successful at 525 mg and 700 mg (unlikely) maybe they will even go with a lower dose given the more safety data for that dose. Possibly even using receptor occupancy test (ROT) to verify or validate dose levels by density? This seems to have disappeared from discussions, but seems keys to personalized therapeutic medicine and even more important if both HIV and cancer get approved around mid-2020 and commercial inventory is limited.
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