RE:RE:Half Of Breakthrough Designations Have Resulted In ApprovalNope, I reject your suggestion, clearly you didn't read my links on Fast Track, Rolling Review and establishing a clear communication with FDA as we go
So that we dont have to wait 3 months to collect data on a USB and submit it all at once.. like a company without a Fast Track.
Please re-read the links. and update your posts accordingly.. Waiting 8 years for some actual progress..
Not to be kicked in the nuts on an annual that says oh we just applied please wait 60 new days...
Like the old days of Health Canada ... heres 75 more days...... then wait for reply 45 days.. etc are we really going to go through that again.
ScienceFirst wrote: So my suggestion of this morning that TLT can take 3 more months before applying, instead of rushing with unsufficient or not clear enough data.