To fully appreciate the significance of Brilacidin getting FDA Fast Track Designation (FTD) investors need to compare the timeline of the only currently approved therapeutic for CV19 which is Gilead’s remdesivir. Note that remdesivir studies have shown a reduction in hospital stays but have NOT shown any improvements in mortality rates and remdesivir does NOT kill CV19 (virucidal). If Brilacidin in human trials proves to be superior in both safety and efficacy, I believe it would be safe to assume that demand for Brilacidin would significantly surpass remdesivir and become the new Gold Standard for CV19 therapeutic treatments. Note that FTD “Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.”
If you follow the timeline below you will see that once Fast Track designation was granted to remdesivir, the following took place:
5 weeks – Emergency Use Authorization by FDA
3 months - $1.6B revenue secured with HHS
7 months- FDA Approval
Will IPIX B-CV19 follow a similar timeline with a superior drug?
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3/26/20 FDA granted Fast Track designation to Gilead for Veklury (remdesivir)
5/1/20 Emergency Use Authorization by FDA
6/29/20 HHS has secured more than 500,000 treatment courses of the drug for American hospitals through September. This represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production in August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials. A treatment course of remdesivir is, on average, 6.25 vials.
Hospitals will receive the product shipped by AmerisourceBergen and will pay no more than Gilead’s Wholesale Acquisition Price (WAC), which amounts to approximately $3,200 per treatment course.
500,000 treatment courses x $3,200 = $1.6B revenue
10/29/20 FDA approved the antiviral drug Veklury (remdesivir) as the first treatment for CV19.
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
https://www.fda.gov/patients/fast-track-break...fast-track
If you follow the timeline below you will see that once Fast Track designation was granted to remdesivir, the following took place:
5 weeks – Emergency Use Authorization by FDA
3 months - $1.6B revenue secured with HHS
7 months- FDA Approval
Will IPIX B-CV19 follow a similar timeline with a superior drug?
========================================================
3/26/20 FDA granted Fast Track designation to Gilead for Veklury (remdesivir)
5/1/20 Emergency Use Authorization by FDA
6/29/20 HHS has secured more than 500,000 treatment courses of the drug for American hospitals through September. This represents 100 percent of Gilead’s projected production for July (94,200 treatment courses), 90 percent of production in August (174,900 treatment courses), and 90 percent of production in September (232,800 treatment courses), in addition to an allocation for clinical trials. A treatment course of remdesivir is, on average, 6.25 vials.
Hospitals will receive the product shipped by AmerisourceBergen and will pay no more than Gilead’s Wholesale Acquisition Price (WAC), which amounts to approximately $3,200 per treatment course.
500,000 treatment courses x $3,200 = $1.6B revenue
10/29/20 FDA approved the antiviral drug Veklury (remdesivir) as the first treatment for CV19.
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy which may be potentially better than available therapy.
Any drug being developed to treat or prevent a condition with no current therapy obviously is directed at an unmet need. If there are available therapies, a fast track drug must show some advantage over available therapy, such as:
Showing superior effectiveness, effect on serious outcomes or improved effect on serious outcomes
Avoiding serious side effects of an available therapy
Improving the diagnosis of a serious condition where early diagnosis results in an improved outcome
Decreasing a clinical significant toxicity of an available therapy that is common and causes discontinuation of treatment
Ability to address emerging or anticipated public health need
https://www.fda.gov/patients/fast-track-break...fast-track
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