Traditionally you'd be right, however, I believe this trial has been done in a manner that's broken traditions, and i believe dynamic action on approval is possible. It doesn't require full approval for DCVax-L with Poly-ICLC, rather approval of DCVax-L and a compendium listing for Poly-ICLC, which has been approved for other applications, to be used in combination with DCVax-L. Keytruda might also be included in the compendium listing.
If this trial had been run in a totally traditional manner, it would probably have ended many years ago and a new trial, structured differently. would have been initiated, and probably not completed for several more years. Fortunately the regulators have become more open to getting worthwhile products through the system more expeditiously. I believe that's why we're where we are, and why we'll get the approval and the compendium listing for Poly-ICLC and perhaps a few others.
Small trials, like those run at UCLA, may be all that's needed to have products like Poly-ICLC, Keytruda, etc added to the compendium listing and give the Drs. choices as to what's best for their patients. The key of course is the approval of DCVax-L as all these other drugs are nearly useless in these cancers if not used in conjunction with DCVax-L.
I realize that many disagree with me, they believe the FDA and others will bounce NWBO's filings because of the unorthodox changes made during the trial, even though they met with NWBO in making them. I believe the UK action will indicate the direction the others take, and I believe that the worse the UK will do is an approval with a confirming trial required in the future. The failure to gain approval that required further trials would delay acceptance of this technology for at least 5 years, and probably much longer, I just don't see the regulators doing that.
Gary
