Relief Therapeutics Holding AG (RLFTF)

[changes_iv]

When comparing the different stages of Covid-19, should critical/severe cases require the same level of efficacy as the mild ones for EUA approval?

Read this from the NIH website:

"Regulatory decisions are made on benefit-risk balance and in a rapidly evolving pandemic two issues come in to play, namely the speed of drug approval and the urgency of clinical needs. The speed of developing treatments to the point of approval is key to protect patients from the infection as quickly as possible."

"Drug development of new biologicals or chemicals, other than vaccines, takes a minimum of 2–3 years even if there is a candidate that has shown efficacy in animal trials and have scaled down clinical trials to 6–12 months. Pre-clinical activities of manufacturing to establish product quality and the necessary safety studies normally take at least 2 years before clinical trials can start."

"Repurposed drugs, however, could appear on the market after simply completing one or more clinical trials. As the medical need for a drug increases and more patients die from the disease, THE BENEFIT OF THE DRUG INCREASES IN THE ASSESSMENT OF BENEFIT-RISK BALANCE."

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7677570/

This should be immediately approved and if there are any lingering questions make it a conditional approval.

~ Zorro, Y@h00 RLFTF finance conversations