RE:RE:RE:DesperationThera2014MJC73 wrote: Bencro-
now you're talking ph3.... I thought the mantra was fast track in early 2016!
Kiddo, we're talking 2018 or 2019 if it goes to ph3,
Even I'm not that pessimistic!
Get with the pump program! We gotta get the sp over $0.50.
He can't assume/take for granted that Phase2a (proof of concept) will automatically lead to fasttrack or breakthrough.
He's saying for stock risk for those of you's that are so concerned, you can't put money in the bank until phase iii success and final nda approval. So he's asking why are you here. Why not wait until 2015 is complete and whether fasttrack is granted or not if you are so worried?
Approx. timeline we have:
2015 is Phase 1/2a
....Phase 2a meetings.
if needed, 2016 would be Phase 2
if needed, 2018 would be Phase 3
Breakthrough could be granted after Phase 2a meetings... which would fall around end of this year/start of 2016 if everything goes according to plan. TLT has a strategy.
Reference
https://obroncology.com/obrgreen/print/FDAs-New-Breakthrough-Therapy-Designation
https://www.medicinenet.com/script/main/art.asp?articlekey=9877
https://www.virginia.edu/vpr/irb/HSR_docs/CLINICAL_TRIALS_Phases.pdf