Hi Beartrap,
They told us in old 10Ks and old conferences that they planned to submit a petition immediately to the FDA for Accelerated Approval if the results were similar to their phase I trials. Has the DMC recently concluded its first IA and made a recommendation? Maybe. Our trial has an endpoint that can be used for accelerated approval. In a very recent post, I quoted a real world example regarding how blazingly fast this process can work -- 78 days from formal submission. That post showed the petition could be submitted in parts via rolling review before the trial ended. Because this is an orphan designation I have no doubt in my mind NWBO (aka: through their CRO) is working just as closely with regulators as that recent real world example I quoted.
Think about what would happen right now if we are in the middle of the rolling review, like the example I quoted, if NWBO told investors they were in the process of submitting a petition for accelerated approval. First this would tell the whole world (if it were the case) that the DMC already recommended NWBO halt the trial for efficacy. What effect would that have on pressure to end the placebo trial? Right. Some people would expect/demand it (the placebo) to end. The real halt imposed. But if we do that, NWBO interferes with the ability to continue to use this trial to gather blinded data information before the petition for accelerated approval is initially approved or denied. Instead a screening halt for new patients is temporarily halted for NEW recruits while the (hypothetical) petition is submitted. If the petition is granted the first time through, the number of screened patients ready for enrollment by that time might be very close to 348. (Full enrollment) This would be enough to use the current trial as the confirmation trial (probably open label in my opinion). If the petition is not granted the first time through, or the FDA states they want to see more blinded data through 248 events, the trial goes on blinded without any public pressure to get rid of the placebo and/or unreasonable disappointment that the FDA wanted more information (that would also leave a large opportunity for a short attack). For now, in the meantime, NWBO meets the hypothetical DMC recommendation half way, preserves the current form of the trial, protects long term investors (not short term unicorn hunters) from another potential preapproval trial, and moves/continues forward blazingly fast to try and get approval.
Under my hypothetical, if we are where I think we are, it would be foolish to throw away early approval just to appease investors' immediate need for transparency. The shorts are playing unfettered during this hopefully short window, and they win this brief round. Woodford wins because he can give us a favorable financing at a low price for him, patients all over the world win because this therapy maintains a chance to be approved sooner than later, and yes, long term investors win.
P.S. Imagine the current enrollment is at 315 with 45 more patients amongst 93 clinics somewhere in the screening process or just concluded the screening process in the German (very large), Canadian (very large) and the U.S. hospitals. Do we really want to instead over-enroll and potentially favor short term progression events (apparently, even 10% to 20% of DCVax-L patients do not respond to therapy) to be counted in the potential second and third interim analysis? This would be illogical. Therefore, under my hypothetical, the screening halt also makes numerical sense.
Respect Risk. Conduct Your Own Due Diligence. Manage your assets wisely. Diversify.
