Theratechnologies Inc T.TH

TWO STUDIES: GO !

[FredTheVoice]

Thats very very good

Best scenario

FTV.

[muslix1]

to much good news for a day... i hope the market will appreciate..

[FredTheVoice]

Should we get use to that ? Onless we prefer one good news and the stock is down !!!!! The company is now trying a different strategy.......three excellent news...... Lets see the market reaction....... But I am sure that the path is clear for NEW INVESTORS TO BE VERY VERY CONFIDENT ABOUT THE FUTURE...... Even Analia...... GLTA FTV.

[scarlet1967]

We knew the oncology will be accepted they main thing is NASH although delayed by one quarter due to addressing some details wil be phase 3 and not phase 2b/3 which is important due to duration and costs of the program will be feasible. The increased sakes despite many jurisdictions are in lockdown due to pandemic is impressive not to mention European sales will kick in late 2021. But I think we

[palinc2000]

I really like the sales increase.....THTX SP could triple when we reach 25 million $ per quarter  

[palinc2000]

  The primary endpoint used to seek accelerated approval will be the percentage of participants achieving NASH resolution and no worsening of fibrosis compared to placebo.  Question Do they know the targeted % and if so why would they keep this secret? Competive or else?

[scarlet1967]

Not an expert but I guess it applies to other NASH trials too so they need to achieve the endpoints in enough number of participants so statistically it is satisfactory for the drug to get approved.

[scarlet1967]

Or to get accelerated approval...

[scarlet1967]

Spartrap made a good point, the cancer program relatively cheap and probably progressing faster will be kicking in before the NASH, on the back of growing sales and analysts covering oncology programs starting coverage of THTX, the SP could appreciate but some meaningful amount, with some early positive news from the oncology program company can raise funds one way or the other or find a suitable

[qwerty22]

My memory is that I've heard or read NASH company execs talk about the drug needing to beat placebo by 10%. So if 10% of patients resolve NASH in the placebo then the drug needs to get 20%. It seems like a low number but it fits with Intercept's data. They believed they had hit their target when the primary endpoint (fibrosis reduction) came in with 11.9% in placebo and 23.1% in the

[SPCEO1]

The FDA shold probably publish a new NASH testing guidance document. A lot of water has gone under the bridge since their first one and they should probably update it based on what they have learned since then.

[qwerty22]

I was flicking thru a presentation by an EMA person which stated that they were planning to update their guidance by the end of 2020 but that got thrown off by Covid. I think we might even see something before THTX iron out the final wrinkles.

[scarlet1967]

I agree they have executed on both commercial and R&D programs which is quite a accomplishment despite restrained resources for a small company. If they can grow sales in the midst of the pandemic they should be accelerating the growth rate post pandemic maybe by some meaningful amount.

[ggg088]

Is that positive response of the "Study May Proceed" from FDA?

[scarlet1967]

Yes.