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Re: rusty8350 post# 1563

Thursday, 09/08/2016 8:36:28 AM

Thursday, September 08, 2016 8:36:28 AM

Post# of 2296
See Rusty's timeline comments in the post I am responding to.

In part:


In FEB 2016 they laid out this plan:

Key Milestones for 2016

• Provide regulatory update on eravacycline program – 1Q 2016

• Initiate IV-only phase 3 clinical trial for eravacycline in cUTI - 3Q 2016

• Initiate new clinical studies to advance the oral eravacycline development program - 2Q 2016

• Advance TP-271 phase 1 clinical program - 2016

• Initiate phase 1 clinical trial for TP-6076 - 2Q 2016

• Present scientific data from antibiotic candidates at scientific meetings - 2016




It's currently the 2nd quarter of the year - So we can assume that right now, they're actively working on Initiating new clinical studies to advance the ORAL eravacycline development program.

They actually stated this in the earnings report - and I'm not sure why it wasn't PR'ed that they started these trials, but I digress .....



“We expect to receive regulatory guidance from the FDA this quarter and look forward to providing an update once we have more clarity. We continue to plan for an additional phase 3 clinical trial for once-daily IV eravacycline in complicated urinary tract infections, and we recently commenced a phase 1 clinical trial as the first step to advance the oral development program for eravacycline.”




We can expect that the third quarter will be when they start the IV only study for eravacycline. That is, unless the FDA surprises them and say's they don't need to do this:

Notwithstanding the outcome of the Company’s ongoing discussions with the FDA, the Company intends to initiate a new phase 3 clinical trial of the IV formulation of eravacycline for the treatment of cUTI in the third quarter of 2016. The Company has submitted the protocol for this trial to the FDA for review.




http://ih.advfn.com/p.php?pid=nmona&article=71358223



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