"Identify which of these are truth or illusion."
"> Brilacidin has received 2 Fast Track and 1 Qualified Infectious Disease Product designations from USA FDA."
That's BOTH. Those designations WERE received but their benefits have been, at best, illusory.
Per the 2015 10K:
"For this and other reasons, such as its high activity against methicillin-resistant Staphylococcus aureus (a leading cause of ABSSSI) brilacidin received FDA designation as a Qualified Infectious Disease Product (QIDP) in November 2014."
"Receiving QIDP designation means that Brilacidin is now eligible for additional FDA incentives in the approval and marketing path, including Fast Track designation and Priority Review for development and a five-year extension of market exclusivity."
Per the 2016 10k:
"The FDA awarded a Fast Track designation to Brilacdin-OM for oral mucositis in November 2015."
Per the 2018 10K (and 2019 and 2020 10Ks):
"Certain of our product candidates, such as Brilacidin for the indication of Oral Mucositis and Kevetrin for the indication of ovarian cancer, have been awarded Fast Track designation."
Per the 2021 10K:
"Certain of our product candidates, such as Brilacidin for the indications of SARS-CoV-2 and Oral Mucositis, and Kevetrin for the indication of ovarian cancer, have been awarded Fast Track designation."
Per the 2022 10K:
"Brilacidin, for the indications of SARS-CoV-2 and Oral Mucositis, has been awarded Fast Track designation."
Per FDA.gov:
"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. The purpose is to get important new drugs to the patient earlier."
"Fast Track designation must be requested by the drug company."
"Once a drug receives Fast Track designation, early and frequent communication between the FDA and a drug company is encouraged throughout the entire drug development and review process. The frequency of communication assures that questions and issues are resolved quickly, often leading to earlier drug approval and access by patients."
A Fast Track designation needs to be used to have value.....its benefits to the sponsor of a drug that is not actively developing that drug are as useless as t__ts on a bull.
B-OM?
B-CoV?
Kevetrin???
If a benefit can't be shown, why list it as if it's an accomplishment? The Fast Track designation is "a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need" and not designed to be a promotional device. All the medical needs that B-OM, B-CoV and Kevetrin were being developed to treat remain unmet.