I agree, but I don't see a partnership until you at least have top line data, and in that circumstance, the partner would have full access to all the data under cover of confidentiality.
I don't think top line is too far off, but we do need the SAP first. Dr. Liau is making a few presentations near term. Even she doesn't know with certainty what the unblinded data will show, but I think she could accurately guess and be about 99% right. What she can share is things like the current statistics for the top 100, she could also say how many are still alive in the trial. Nothing says how many in the top 100 are on the vaccine, likewise how many of those still alive are, but I think Dr. Liau could guess and be very close, if not right on the money. I suspect her guess in both cases would be nearly all received the vaccine.
From the time they unblind, I suspect it won't take more than a couple days to establish top line data, which normally only is a few paragraphs summarizing the trial. The full data presentation is substantially more, but with substantial efforts I believe it can be done in a matter of weeks. Preparing the BLA for presentation to the regulators will take substantially longer. If we unblinded today, I suspect that we'd be hard pressed to submit the BLA by the end of the first quarter next year. If we can do it during the first half of the year, we could have an approval by the end of the year given the six months our FDA takes. I don't know how quickly the other regulators may act. Frankly, I believe if the FDA has approved the manufacturing capability previously, when a trial is clearly positive they ought to be able to approve it in a matter of days or weeks, but the reality is, they'll take most if not all of 6 months, and that's for products with high priority, for others they take a year.
Frankly, if on submission of a BLA or NDA the products could be available say at half the suggested list price, I believe many patients could see benefits, and many lives lengthened, if not saved. I cannot tell you the amount of time that I've seen wasted by drugs that clearly should have been approved that were delayed by FDA's questions or additional demands. I believe that all approved drugs should go into Phase 4 Trials where all results were fed back into an FDA run database that was available to review for all.
Gary
