InvestorsHub Logo

biosectinvestor

11/14/19 2:01 PM

#251689 RE: trocprofit #251670

It’s “informal” approval in the same sense that you do not proceed with an NDA until they stop asking questions. They do not “approve” those either, but it would be foolish to assume that despite still engaging on a trial design or questions on an NDA that are material, that you can just go ahead and start your trial.

skitahoe

11/14/19 2:23 PM

#251693 RE: trocprofit #251670

I agree, the only question in my mind was how long the FDA should be given to do a review before presuming it's okay as is. No matter what the FDA does, or doesn't do, they're in control when it comes to approvals. Drugs are approved all the time that fail to meet preliminary requirements, and likewise approvals are delayed for drugs that do meet requirements as the FDA asks for something not specified when they originally were put into trials.

I know some here have invested in CVM, perhaps they have found a disease their cure works for, but I wouldn't bet on it. Once something has proven not to be of harm, it's developer is free to try it as they choose. It is their money, and the FDA doesn't prevent them from spending it as they choose. In the case of CVM, I've seen them issue essentially the same document, with only a few words changed, on numerous occasions. In each case they express confidence that their drug will benefit people suffering with XXXXXXXX, and they intend to initiate a Phase 3 Trial with it. All the change in the release are the XXXXXXXXXX's and people just keep coming forward to buy their newly issued shares on the announcement. I've observed this over multiple cycles and sadly they're not violating any laws in operating this way. For those in the company now, maybe this is the time their cure has found it's disease. I invested in it when it had the symbol HIV as it was AIDS that they believed their drug would cure, that was probably 2 decades ago, the drug hasn't changed, just what they're targeting it at. Of course when they failed with AIDS, they changed the symbol back to CVM.

Gary