"Shortly" “We will shortly request a meeting with the FDA and the EMA to ascertain the phase III clinical trial approach required to obtain approval of tesamorelin for the 2 treatment in NAFLD/NASH"
What I am hoping we get out of Oct 2,3 at the very least, is a more definitive timeline. As we have experienced, management’s expectations may not be as aggressive as our own so I would like to better understand their definition of “shortly”.
I am not experienced in the FDA processes, so in looking at the
FDA's Guidance for Industry: Formal Meetings Between the FDA and Sponsors or Applicants, I would assume THTX will request a “Type B (EOP) Meeting”. For this type, the meeting request response time is 14 days and then the meeting scheduling time frame is 70 days.
So if the FDA processes take about 3 months, how long will it take management to get the meeting request package together? Is 4-6 weeks a safe assumption? This would put us at late Feb or early March if there are delays during the holiday season.
Given the history of delays with THTX, I won’t hold my breath. All we can do is hurry up and wait.