RE:Uphill battle in NASH for THI think you are correct it seems like he only looked at one of the trials if I recall correctly in one of previous trials they had over 900 patients nevertheless the last trial had much fewer patients but again if I recall correctly they had F2/3 NASH patients there having said that they are planning to have some 900 patients enrolled in upcoming phase 3. As for translability from NAFLD to NASH as per company's outdated 25% of adults are suffering from NAFLD and up to 5% with NASH, so he could use those statistical numbers if he is referring to equation between NAFLD/NASH again I am not sure what is he referring to by saying the translability of data NAFLD if untreated will result in NASH, both in HIV and general population if he is referring to progression of the conditions.
Quite frankly his statements to me is not clear but you are right CFO and scientific advisors of THTX need to do some heavy liftings to clear the air prior and during the phase 3 trial possibly more webinars with the KOLs present.
SPCEO1 wrote: The following are comments on Egrifta in NASH from a US analyst. I would be interested to see if any among our medically competent group here would like to comment on his thoughts:
"I have seen their NAFLD data – the data is from a small trial in HIV patients with NAFLD – the MRI data is OK. True placebo in non HIV patients with NASH (not NAFLD) is like 15% which diminishes the effect there which makes me skeptical.
Also the question is what is the translatability of data from HIV patients with NAFLD to actual NASH patients? I don’t think we definitively know that and I am not sure they have data there.
Seems high risk to go straight into Ph3 NASH trial.
I have seen companies with better drugs and better data fail in NASH. It is a very tough space."
I think this is an overly harsh view of TH's data but it is nevertheless the standard view and the reason why the stock is not getting any respect for its NASH efforts. A few thoughts from a non-medical guy:
1.) MRI data - they had biopsy data so why is he focused on MRI data?
2.) I get the impression he may ahve only looked at one of Grinspoon's trials
3.) There were some NASH patients in the last Grinspoon trial if I recall cirrecctly, so it was not all NAFLD
4.) I thinnk AKRO had no placebo effect in their trial but their stock is still highly valued by Wall Street.
5.) While we don't know exactly how the data will translate from hiv to non-HIV patients, it seems fair to expect it to translate pretty well. I have to believe the tenedncy would be for Egrifta's impact to be better rather than worse on less difficult livers.
6.) While it is clearly high risk to go straight to phase III without the phase II data on non-HIV patients, can TH get a little respect for giving it a try or are we to conclude that Paul and his team are a bunch of kooks for doing so?
7.) Everyone has seen companies with better NASH data fail because, technically, TH does not have much, if any (depending on how you want to look at their data) on non-HIV NASH patients. And every drug has failed so far. So, I am not sure his last statement is worht much. I would have preferred he tell us a little more about why he thinks Egrifta is an inferior drug.
In the end, we can protest all we like but this does seem to be the prevailing view in the marketplace and is why TH is not given any value for its NASH program. Paul and his team need to understand this and provide analysts with a well-reasoned rebuttal.