Brilacidin FDA CV19 human trial durations will be
Post# of 72447
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Posted On: 07/01/2020 2:15:43 PM
Brilacidin FDA CV19 human trial durations will be measured in weeks not months. With CV19 cases still climbing in many states across the country there is no shortage of patients that will be eager to sign up for any trials. Getting treatment as early as possible for CV19 is critical. Many CV19 patients have mild symptoms initially and some end up hospitalized 2 or 3 days later. Some need intubation or die within days.
My guess is that Brilacidin will initially have a short 3-4 week CV19 Phase 2A human trial to validate dosing protocol based on advanced RBL testing (see 4/27/20 PR for details) to ensure the same safety profile that was proven in the B-ABSSSI phase 2. From an efficacy perspective I believe showing half or better results compared to Brilacidin’s outstanding RBL lab results would catapult Brilacidin to the top of the CV19 treatment options.
The FDA at this point will IMO open up Brilacidin for a parallel effort with a combination of a Phase 2B/3 trial along with Expedited Approval through either or both of Emergency Use Authorization and/or Compassionate Use. Brilacidin could very well be FDA approved for CV19 by fall of this year.
IMO any timelines for the above will initiate when grant funding is approved and will be completed prior to 11/3/20 for obvious reasons.
My guess is that Brilacidin will initially have a short 3-4 week CV19 Phase 2A human trial to validate dosing protocol based on advanced RBL testing (see 4/27/20 PR for details) to ensure the same safety profile that was proven in the B-ABSSSI phase 2. From an efficacy perspective I believe showing half or better results compared to Brilacidin’s outstanding RBL lab results would catapult Brilacidin to the top of the CV19 treatment options.
The FDA at this point will IMO open up Brilacidin for a parallel effort with a combination of a Phase 2B/3 trial along with Expedited Approval through either or both of Emergency Use Authorization and/or Compassionate Use. Brilacidin could very well be FDA approved for CV19 by fall of this year.
IMO any timelines for the above will initiate when grant funding is approved and will be completed prior to 11/3/20 for obvious reasons.
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