In the U.S. the FDA came out with their proposed new guidelines...

In the U.S. the FDA came out with their proposed new guidelines for approving Alzhiemer's drugs, that provides an accelerated path to market for any drug showing cognitive or functional/executive improvement. The acceleration to market is granted with an agreement to perform a follow-on study but the drug would be approved for use during that period.

I believe an announcement like this, and coming this early provides Prana the opportunity to meet with the FDA in review of all the trial protocols in assurance of meeting all such requirements of a qualifying follow-on study and lays the groundwork for acceleration to market, and possible forgoing entirely a full-blow phase III trial.

The earlier 12 week study, plus the Reach2HD study now concluding both provide additional human study data in support of such a consideration.

Taken in this context, our market cap assumes a traditional pipeline path that includes a phase III trial - nearly always assumed across all biotech except in rare circumstances, but the FDA and even the G8 conference are acknowledging the global consequences of AD - and they are ready to act.

Prana has directly responded in kind to the new proposed guidelines for acceleration. So with our market cap based upon and earliest to market expectation of 2016 - what should we be trading at if PBT2 is approved to the U.S. market in 2014 having a follow-on study already planned?

We should be trading above $10 right now. And if disease-modifying results are announced for Reach2HD in October one could double or triple that, and if Imagine results prove out it is almost too unimaginable for me to consider.