I have absolutely no doubt the FDA will approve the vaccine. The question is how long will it take.
In the past I've been certain that other products would be approved, and every one was, but in some cases the FDA delayed approval by a few years. In some cases they required additional trials, some of which were underway already, but in some cases new trials were required. In other cases data that hadn't been requested previously was suddenly required and substantial time was needed to get as much of it as possible. Still in other cases they were unsatisfied with the commercial manufacturing facility and substantial time was required to make necessary improvements and gain the inspection and approval.
My point is, it's up to the FDA once the company files. If approvals have been granted, and the vaccine's available in several countries, perhaps including our neighbor, Canada, I think it would encourage them to act quickly, however, I have seen products thought to be sure things take years. My first experience with options came when Genentech's TPA was up for initial approval, everything you could find said it was a sure thing. Without a lot to invest I bought slightly out of the market calls for after the PDUFA date, if the stock went up as dramatically as many forecast, with margin I may have been able to convert most or all of the option to stock in my account. The FDA asked Genentech for historical data on how patients did long term, data Genentech didn't have as it wasn't a part of the trial requirements, and approval was delayed a substantial period of time, the stock tanked, and of course my options were worthless. Nothing is absolutely certain with the FDA, but I'm certain as I can be that at some time the FDA will approve DCVax-L and if DCVax-Direct is all we believe it to be, it too will eventually be approved.
Gary
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