OK...so this is only a theory...Delcath were told they could not discuss data from EAP or Europe. The vote was fixed by the wording of the question. Next..big pharma comes and "rescues" the company at a cheap as chips price and runs phase 4 on the gen 2 filter. Cheers and party hats all round. Honestly, I'm having a moan because I've lost a bit of cash, but what about those patients and people without jobs tomorrow?
The possibility of a need for a Phase IV for Gen 2 is mentioned in the FDA notes, so why are you surprised that someone would mention it here? Phase IV studies are common as follow-ups after a product starts to get marketed. The danger here is that the likelihood that DCTH will be approved is very poor now, so they may just have to focus on Europe.
The same sentiment could be applied to dndn. Sure , when it crashed because two pharma assassins did a letter writing campaign, a lot of people lost money, but I know a couple of people who were financially destroyed by their despicable actions, and lost their health as well.
I'm sorry to hear that Obnox. Frightening. What about gen 2 EAP? This does smell funny, because gen 2 is clearly OK and if Delcath had presented that' with QOL data, I think it would have been yes on condition of phase 4 trial. So, whose decision was it to stay tight lipped? Weird... Also, what was with the extra paragraph on the question? I suppose it's all immaterial, because DCTH is toast for now and it does look to me like twenty five years of hard work sabotaged. They should have withdrawn the application and asked for a further trial...should've, would've, could've.