Ayala Pharmaceuticals Inc (ADXS)

[Meishairwin]

Ignatius, yes, accelerated approval is always possible -- and I hope we get it! But, a prudent investor would not be betting on that or disappointed if it does not happen.

Consider, EU approval is not likely before 1Q2018, IMHO. We have not yet filed for it and once we do there's at least a 150-225 day cycle, and it's not even clear how that works...things always take longer than expected. I'm not sure when an interim look at AIM2Cerv might occur, but unlikely before 3Q/4Q2018? Accelerated approval, if it followed, might take another 6-12 months, so we're looking at mid-2019. That's a year earlier than AIM2Cerv is scheduled to end, so that would be good...but that's the 2 years (or 3 years) from now I was referring to.

And to your point about appreciation over the next 2-3 years, yes, I would expect there would some be on news of other trials, the neoantigen work, and other things. It might be as much as 2X-3X current pps. But, getting to that 5X-10X-20X (the latter being the much-bandied ~$6B valuation) pps advance...that will take the near-certainty of AXAL approval, which I think is still 2-3 years...and a lot of risk...away.