New video out by AF. He's an idiot. What is his agenda???? Who is in his pocket????
He thinks DCTH will fail the panel because of safety concerns. He said 2 people died during the trial. Duhhh they had advanced liver cancer. They didn't die because of CS.
he called arna and vvus both to get rejected at adcom, i banked BIG and again BIG on approval which he said would not get FDA approval. Ask the FOLD crowd the followed him when he said it would have positive results and failed, lol....yeah....he is about eyeballs bringing in the eyeballs is what makes him the money.
Adam F. has definitely been WRONG more than right. It is easy to pick against this because most of them are CRL'd.
I don't care what the ADCOM says, the FDA has guided DCTH by the hand to get this approved. Adcom will be divided for sure...I hope there are some reasonable people that can see through the mist that this device can be very beneficial...I think the FDA postponed this to be provided as much info as Delcath can come up with to prove it's worth.
So, I am betting on FDA approval.
i thought he said they died during the procedure which is concerning. perhaps the panel will ask again for another round of trials to insure safety protocols unless Delcath can prove otherwise. I am long but this is seems worrisome. anyone?
When the advanced melanoma metastasizes to kidneys, colon, brain, etc. how can treatment for the liver prevent death in these cases? The ADCOM is for liver treatment only, and if a patient dies as a result of brain cancer, how is that a negative safety outcome in the clinical trials for Delcath?
Isn't the phase 1 trial supposed to solve the safety issue? So I assme that safety is the main concern for A. F. ........ there are doctors on the ADCOM panel.. You would think that they are aware of the safety issue and it is no suprise to them. Maybe AF thinks that those professionals are ignorant of the facts.
Will there be 12 members in the ADCOM panel?
AVEO had a run up while DCTH did not. Besides, the problem with AVEO is much more severe since it did worse compared to BAC while Chemosat equally didn't show survival benefit, there is a positive trend and also if you exclude cross over, Chemosat would have a survival benefit.
Frankly, Adam F. doesn't have many arguments against Chemosat so that he had to trout out the old treatment deaths that were greatly discussed back in 2007.
if thats the same article, I think they said that they died from the drug they were using vs the cancer so that was the concern but I agree that these people are dying anyway and an extention of life plus a new treatment to consider should far outweigh any negative; why would fda allow them ot open in co ahead of time and reject the changes that they suggested the co make......