RE:A Speedy Phase 2 Path Directly To Approval...?Hempdoc wrote: In the event Theralase attains positive intermediate results at 6 months, my bet is they attain approval for a request for “breakthrough” designation. This approval could be handed down within weeks of their request. The “breakthrough” designation provides the shortest distance from start to finish for drug approval. According to a 2017 JAMA article, half of the reviewed drug candidates (between 2012 & 2016) that received this designation “sprinted from the start of human clinical trials to FDA approval in 4.8 years or less, compared with a median start-to-finish time of 8 years for drug candidates with no expedited designation”. Since the breakthrough designation program was instituted in 2012, the FDA has been increasingly approving year over year more drugs (especially oncological) based on less & less data. A new approval bar has recently been set, & thankfully for many desperate/dying patients, that threshold for approval continues to tumble from its heights just in the last few years. Theralase finds itself in a great position at a no better time to reap a lot of reward in a short period of time, & ultimately affording its shareholders a lot less pain...
I know some of you may not like President Trump (perhaps partly justifiable), but his FY 2020 budget request for the FDA includes a $428 million “increase” (from FY 2019) to advance the development of safer & more effective drugs/medical products.
With the recent withdrawal of the shelf prospectus, I expect funding/good news should be just around the corner & Ph 2 should proceed without significant delays. As for its completion, will leave that up to the FDA.
So what are you saying, if TLT recieves breakthrough designation in the latter part of this year investors would still have to wait until 2024 to see if the FDA approves the treatment? That would mean a phase 3 trial for sure. Not what the average shareholder wants to hear but nevertheless probably an accurate prediction. Where is this corner that's just around the bend? Investors have been waiting over 5 years and they still haven't been able to find the elusive " just around the corner."