LC, while your 5% seems small, what you fail to say is it's roughly a 50% increase in the numbers that make it to 5 years, and the likelihood is that those who make it 5 years will live far longer than that.
The FDA has often approved drugs that permit 10% of the patients to live longer, we're talking 50% living longer and many others who lived less than 5 years still living longer than with SOC treatment.
Of course you completely ignore that adding Poly-ICLC or other therapeutics should move that 5% to over 50%, but only if used with DCVax-L. I grant the evidence is only from a small trial, but it's none the less very definitive.
Of course the regulators could ignore all this, they could simply say, go, get out of here, spend another few hundred millions or more and take another decade to bring me proof that's better organized, done the way I demand it to be. They can say, we don't care about the hundreds of thousands of more who won't get the treatment while you're doing the trial our way. I simply don't believe that will happen, I believe that all four regulators have agreed to the changes that have been made in the trial protocol, I believe they all know the benefit that the addition of Poly-ICLC will bring, and while they may ask for a confirming trial that proves it, I believe they'll all approve and do so in a timely way.
Approval will mean nothing if the vaccine can't be produced in the needed commercial quantities, so I also believe it won't be that long before the EDEN Unit is approved so that sort of production is possible without years of constructing and certifying tiny clean rooms for manual production of the vaccine.
The company knows the BLA that's filed with the FDA must provide for commercial production in the US, the facility has to be approved prior to approval of the BLA. I don't believe they file until they're certain that before the end of the 6 month PDUFA period a facility equipped with numerous EDEN units will be acceptable. I'm not certain, but believe the other two regulators can accept DCVax-L that's manufactured in Sawston regardless of whether it's manually made or made with the EDEN once approved.
Years ago I frankly thought investors hurt the DNDN approval process by taking activist actions in an attempt to force FDA actions. Frankly if the regulators turned down DCVax-L something similar, but more professional, would be something I think many of us could support. I don't believe anything like this will be needed, but I can better understand what DNDN investors went through back then.
Gary
