My best guess is Mono enrollment will be right at 200 by the middle of October. I know they are not having any difficulty enrolling unlike the Combo Trial. The Paulson raise will give them the needed $ to open more sites and hopefully hit 300 by years end.
As for BLA. I believe they will get approval to submit their BLA this year from the FDA. Putting that application together and submitting will takes us into 2018. The important thing here is once the FDA gives their approval to submit it is a mechanical event. Approval to submit by the FDA adds tremendous value to Pro-140 because it means the drug has a pathway to commercialization. If BLA is approved along with the blessing of AA and BTD by the FDA the likelihood of an Organic uplist is quite probable. This is what the company is shooting for to avoid a R/S. they know they need multiple events to happen to get the pop. They also know making it to either the Nasdaq or NYSE will garner institutional investment and visibility. That is the pathway to the kind of valuation that many here are hoping for.
It's all about how the FDA views the PE data. That is why so much caution is being taken before locking the Combo Trial and unblinding. They will continue to enroll until the FDA concurs. The only issue the FDA can bring up is you need more patients because some of your patients don't meet the profile. Believe me this may sound over cautious but at this stage it is the right approach. Botching this up would be a serious set back. It's not a delay it's prudent business.
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