It's in the trials and the company has the money to fund it so it's moving forward.That pretty much covers it.
I'm thinking it should go pretty quick since it's just going to be revisiting the original submission.
Well we'll have the trial timeline but the big question is how long will the FDA move on it.
I'm thinking they knew this was coming(and probably knew what was going to be needed from someone inside the FDA)but couldn't legally put out a PR until they received the letter.
I guess what I'm wondering is does it pre-date 115 and go back to 109.I also don't think NW would do anything while the trials are in progress."We have an obligation to use commercially REASONABLE EFFORTS to bring the subject inventions of the Licensed Patents to market."
I thought if the FDA needed more study data on it that it would be there.What irks me is that these are the details that the company should be giving us;not just glossing over it.I'm almost 100% sure that's the study.After I posted this I read the transcript and they said it was going to be a small study and the time frame is correct.
This is the time frame that was on it.
Estimated Enrollment: 10
Study Start Date: January 2016
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)