RE:RE:Impact of a FDA Breakthrough designationHey LS29, great to see you posting again, your common-sense posts are very relevant. I have also wondered for some time now if TLT has used the access to FDA that was a major benefit of FDA fast track designation. TLT has been silent on this. However, I agree with you that if they took proper advantage to establish a 'rolling review', even though patient numbers have not yet fully met BTD requirement, it should exedite FDA review/approval when the total patient numbers have been met.
LaserStock29 wrote: Has Theralase utilized it's fast track as to get a 'rolling review' and keep communications with FDA.. and get a BTD going and not wait to submit a full package at once.. where shareholders will look at an NR.saying wait another 60 days until the AGM?
Has Theralase applied for a grant for covid 19.. usually these grants take a good bit of time.. aka terry fox grant. 1 year.
Been 8 years of reading how other companies valuations go up for one reason or another and we get jackshi*.
Id sure like to know how THeralase has utilized the Fast track designation in forwarding the BTD efforts..as so that we dont get kicked in the nuts with a hey it's MAY annual and wait 60 days