fast track designation?, page-8

There is nothing at all logical to selling below $0.05 as said many times if it's large longer term holders holding prior to the rise then they're terrible traders and who knows how they came about their capital in the first place if they couldn't exit for a large profit over the 8 days that it traded in the range $0.05 / $0.092 / $0.06 while turning over the equivalent of 150%+ of the registry.

Only people that could be selling profitably (of course many of us could from before the rise but if you didn't sell much higher when it was up there then obviously you have no intention to) would be those that entered in the 70M odd that traded post RI in the 11 day period that it lulled below $0.05 & touched as low as $0.041.


FWIW Fast Track Designation, Breakthrough Status, Accelerated Approval, Priority Review all pretty much come under the same umbrella as Orphan Designation. Now SM6 has ODD it makes the others much easier to come by. The only thing is and maybe the reason at this point they are not pushing for them is the clinical trials are being undertaken in Europe & guise under EMA's Orphan Drug Designation. Until SM6 moves to clinic in the US and under FDA guidelines it's probably not an impetus to gain the others yet. In saying that though now SM6 has been granted ODD by FDA it's a big value add & will bring interest from others hence why imo quite possible we will see someone else come in & move to run another trial concurrently in the US. Why would they have applied for and been granted by FDA if they had no intention in broadening the scale ?