Theratechnologies Inc T.TH

Almost 8 weeks..... since they said, in coming weeks

[Dcutter101]

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[Garp1]

It should be said more contextually like:  it's been almost 2 months since they said, in coming weeks

[Bucknelly21]

I'm not sure what you guys are implying, you or I have no idea if it's already been done yet. Most likely it has.

[palinc2000]

I for one was hoping thatt hey would have issued a PR upon submission but I see near zero chance that it has not been filed,The imminent comment by Paul meant just that ,,,,,The clock has been running a couple of weeks and FDA s response should fall within the expected time slot

[Wino115]

Knowing the exact day isn't all that helpful given regulators have a wide period to review it and with COVID we know those are somewhat extended beyond the normal.  So it may be easier to think that regardless of whether it was filed last week or in 4 weeks, they should pass the regulatory issue towards the Feb, March timeframe and ramp up the study after that. I know the FDA doesn'

[Spartrap]

No, they haven't. It's an IND, it's 30 days top for a negative answer, and a positive answer can come any day before that. Also the title of this thread makes no sense to me. The NASH announcement was on Sept 10th, that is 3 months or 13 weeks ago.

[Spartrap]

Sorry, I didn't understand you were considering the full validation process (FDA+EMA). In Europe, things are a bit more involved as there is a general EMA decision, followed by a collegial validation by concerned member states, with lots of back and forth possibilities but with tight deadlines. The process is called a CTA (clinical trial authorization). It goes through a centralized portal but

[Wino115]

Thanks for the intell. This makes it sound likely we would have FDA first, followed by EMA anywhere from 1-3 months later. I suppose the only thing that does is that the Euro centers where they were going to set up the trial will start later. I believe there were 3 of their advisors from Europe, but they all seemed to be involved in the HIV side of it if I recall correctly.  I'd need to

[Bucknelly21]

Despite what anyone thinks here, it's very unorthodox for a company to pr the filing. It's not a "real catalyst" if you all were hoping that it would create a spike in sp it may for a minute but nothing lasting. The main pr would be trial initiation. That's what I want to see. Also the fda doesn't just stamp approval for a trial, they give strong recommendations. There is