Really good article on FDA process3 Jun 2023 09:14
Https://www.advarra.com/blog/how-the-ind-30-day-hold-impacts-clinical-trial-activities/
This article gives me more confidence that the hold will be resolved in time. I also spoke to a friend in the pharma industry and he said that nearly all covid novel treatments were stopped by FDA pending more clarity. This is a cancer drug and its totally normal that even the slightest clarification would be needed.
I am happy many traders sold off on friday. This has now created liquidity and a platform for new investors at a very low price.
The statements from the article give me confidence :-
Before the FDA permits a pharmaceutical drug product to be lawfully marketed, sponsors are required to submit information about the product’s safety and efficacy so the FDA can determine:
“Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.
Whether the drug’s proposed labeling (package insert) is appropriate, and what it should contain.
Whether the methods used in manufacturing the drug and the controls used to maintain the drug’s quality are adequate to preserve the drug’s identity, strength, quality, and purity.”