I've recently seen NWBO doing much the same thing. I believe that they've worked closely with the 4 regulators involved with their Phase 3 trial, but in choosing the UK to go after first they were choosing the regulator most likely to approve the quickest. They're a much smaller company than Anavex, and they've used contractors to do much of the work. I would suspect that it's the case here as well, and likewise they're going to the first regulator they believe will get the fastest approval in each indication.
I think it's a positive that it's the FDA they're speaking with on RETT's, far from a guarantee, but an indication that they believe it's possible. The FDA isn't about to tell them that if they submit, it will be approved, but they may encourage them to submit so that they can review it in greater depth. If they suggest doing further trials they're essentially saying that a submission would certainly fail. It's very possible that after reviewing an NDA they'll ask for further trials, but it's also possible that they'll conditionally approve, with confirming trials required while they're being paid, and of course it's possible they approve with no conditions. The question is what they're told by the FDA.
Many years ago IMCL, the developer of Erbitux, was telling the world that all was well with their Phase 3 Trial with the FDA, while the FDA was telling them of shortcomings in the trial. It resulted in a $3 billion partnership with BMY before they announced the FDA had rejected their filing and insisted on further data. This is the case that put their CEO and Martha Stewart in jail for insider trading, but ultimately Erbitux was approved. It changed the laws so the FDA could speak out if their position is being misrepresented. Generally few companies say little about what they're being told by regulators. I believe the others pretty much follow the FDA so you don't want to risk saying something, and having a regulator correct what you're saying. Better to say nothing until you can say something official, like our product was approved.
Gary
