Theratechnologies Inc T.TH

FDA accepted Intercept’s NDA for NASH!

[scarlet1967]

https://ir.interceptpharma.com/news-releases/news-release-details/fda-accepts-intercepts-new-drug-application-oca-treatment-pre

 

How many “cases of death” have been associated with Egrifta with a known dose which have been tolerated by tens of thousands of patients??

Yet FDA has apparently accepted Ocaliva’s NDA for fibrotic NASH patients. A drug which can cause death due to inaccurate dosing guess why due to liver injury.

It will be interesting if approved to see the box warning/warnings.

Again Tesamorelin is safe with a well tolerated dose which can help potentially NASH patients but definitely won’t harm them.

 

 

“On September 21, 2017, FDA warned that the liver disease medicine Ocaliva (active ingredient obeticholic acid) is being incorrectly dosed in some patients with moderate to severe decreases in liver function, resulting in an increased risk of serious liver injury and death. 

Since Ocaliva approval in May 2016, FDA received reports of 11 cases of serious liver injury and 19 cases of death associated with Ocaliva. The FDA's Adverse Event Reporting System (FAERS) includes only reports submitted to FDA, so there may be additional cases about which we are unaware.”

 

https://www.fda.gov/drugs/fda-drug-safety-podcasts/fda-drug-safety-podcast-fda-warns-about-serious-liver-injury-ocaliva-obeticholic-acid-rare-chronic

[Wino115]

Any news validating any portions of the overall NASH therapeutic market as being potentially a commercial windfall for those getting in early is a positive for the projects in the P2/3 level. There's a lot to go for regardless of the first few entrants. That Akero market cap sort of pisses me off though....

[Trogarzon]

No recognition yet we have all these KOL's like Greenspoon, Loomba, Anderson preaching for our drug... it's mindbogling like our CEO likes to state.  I meen when a Pharma signs a deal they must take a word of advice for these people.  I can't beleive they have people like Greenspoon that studied Nash for the past 20 years in house.  The guy has been sponsered like tens

[scarlet1967]

        Well their valuation is based on “EFX is a multi-modal investigational drug that holistically confronts NASH”  So one drug multiple phase2a and b trials has convinced the market to ascribe 2.2B market cap to the company. It shows how the market is valuing NASH and its financial prospects. My frustration isn’t about Akero’s sky high valuation

[realitycheck4u]

This post has been removed in accordance with Community Policy

[Trogarzon]

It's like a house that's been on the market too long....

[Trogarzon]

This thing is beyond dead... no pulse....

[SPCEO1]

It is still breathing and has a pulse. But it is very quiet. That might mean good news is developing (NASH partnership, cancer developments), bad news is developing (cancer is being shelved, no interest in NASH) or both. Obviously, there are other possibilities too. One thing we have heard is that the interest in NASH really has picked up considerably since MDGL reported their positive results. My

[palinc2000]

IF and its a big IF THTX is in the process of negotiating a deal in  Nash we can assume that it will be very complex ......because Tesamorelin is already in the market for the treatment of Lipo....unless THTX retains all rights on Tesamorelin for  PLWH(lipo and Nash)

[scarlet1967]

    https://aasldpubs.onlinelibrary.wiley.com/doi/10.1002/hep.31177   https://pubmed.ncbi.nlm.nih.gov/36642292/   Speaking about PLWH and suffering from NAFLD/NASH the prevalence of this group of people is much higher than NASH in general population and many NASH trials have excluded HIV patients due to drug drug interactions among others. About 1.2 M

[palinc2000]

  I can see a big pharma not wanting to carve out PLWH in a Nash partnership and that might become a sticky point..Dont know what Paul would do if offered a substantial amount of money for selling all rights to Tesamorelin (upfront sum plus royalties) I guess it all depends on how substantial the amount and what he would acquire as replacement... This is for sure  very far