Saturday, February 13, 2016 8:24:40 PM
When the company started touting method A vs method B, I called it total BS. Now the company doesn't even bring it up anymore. I still think that direct was a good try, but one has to accept that it was a failure. Their direction with their p2 IMO will be a waste of time and resources. I would rather see something like the UCLA p2 trial that seems to be running in stealth mode being done with Direct in solid tumors looking at RECIST response for efficacy signals. But as flipper pointed out, why hasn't the direct program p2 portion started already?
For all my negativity, I really hoped that DCVAX-L would have worked. Direct was just a diversion for me and I never expected it to work. But the most disappointing finding was that this p3 trial was not a continuation from their pI trial. Who changes the vaccine component mix going into a p2/3 trial design without being crazy. I hope their excuse will be that the FDA required them to remove the TLR agonist from the trial design. DCVAX-L could have been the Gorilla in the room compared to CLDX, IMUC, or any other immunotherapy companies in GBM, but now it seems more like a wasted opportunity to answer the efficacy of pan-antigenic vaccine approach.
For all my negativity, I really hoped that DCVAX-L would have worked. Direct was just a diversion for me and I never expected it to work. But the most disappointing finding was that this p3 trial was not a continuation from their pI trial. Who changes the vaccine component mix going into a p2/3 trial design without being crazy. I hope their excuse will be that the FDA required them to remove the TLR agonist from the trial design. DCVAX-L could have been the Gorilla in the room compared to CLDX, IMUC, or any other immunotherapy companies in GBM, but now it seems more like a wasted opportunity to answer the efficacy of pan-antigenic vaccine approach.
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