They have a small and very loyal group of shareholders that are holding out. Maybe a few weak hands that are not long investors. They are holding out for an unambiguous end to this story which will result in a short squeeze never seen before due to the ‘hundreds of millions of illegal, naked short shares.’ Those are LGs words quoted, not mine. I used a single mark instead of two because it may be slightly paraphrased.
What advantage do they get from disclosing? Phenomenal data was met with a 70% decline in share price. Updating Clinicaltrials in US, and thus finally speaking for FDA, with only the two endpoints that are a priori after the analysis was met with no gain. That analysis was performed more than a year ago, but the SAP was not rejected by FDA as Dr. Linda Liau had communicated earlier this year. FDA ‘approves’ a final product, otherwise they don’t reject which is not the same. You cannot speak for FDA without their permission to do so.
After you are approved to market, you submit your marketing materials to DDMAC or the biologic equivalent. If they don’t like them, they have 30 days to reject or comment. When neither of those occur, you are ‘approved’ to continue using them. But as most everything FDA, they reserve the right to change that status at any time immediately and sometimes do, same thing pre-approval. They only approve a product for sale & marketing. Everything else for the most part is not rejected.
Ask yourself, what changed that allowed them to feel safe speaking for FDA and why post only 2 of 6 endpoints? You can’t speak for FDA.
PS - If you call yourself a drug and not a food supplement, you cannot market a branded product without FDA permission or approval. People like to bash me, but they started to market a Branded product at ABTA.
