RE:Back to the MGH/DrG announcementI think it means ...
"We never announced that the meeting had taken place or the date of that meeting, the only timeframe we discussed is that we would report on the outcome before the end of the first half of 2020."
That's different than what has been said here, so there is certainly miscommunication ... again.
Another long, unknown, no update, nervous that the markets will tumble ... waiting period. siiigggghhhhh
-LT
qwerty22 wrote: I sent off a question to Theratech about Dr G's role with the regulators and got a reply that was somewhat cryptic. Let me know what you think it means.
Question
Could you help me understand one point in today’s press release?
You wrote
“ The MGH, through Dr. Steven Grinspoon, who is chief of the hospital’s Metabolism Unit, has agreed to assist Theratechnologies in connection with the Study design, selection of optimal patient population, dosing, Study duration and other safety matters and to participate, if need be, in regulatory meetings with the United States Food and Drug Administration (FDA) or the European Medicines Agency (EMA). ”
I had the understanding from previous statements made by the company that the type C meeting should have already happened by now but the last part of this sentence suggests that it is still ahead of you. Can you confirm if you’ve already had the meeting with the FDA wrt the clinical trial for NASH in HIV?
Answer (Dubuc)
The statement is not specifically related to the requested Type C meeting. This is a multi-year agreement, and Dr. Grinspoon will participate in any meeting with the authorities (should we require his help), and will assist us in the design of the study, which will be guided by the outcome of Type C meeting. We never announced that the meeting had taken place or the date of that meeting, the only timeframe we discussed is that we would report on the outcome before the end of the first half of 2020.