Theratechnologies Inc T.TH

RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Salvage therapy new paper

[juniper88]

Still the same question: Were any of these groups specifically excluded and why? As for HIV+ patients why are they excluded? This is an important question.

qwerty22 wrote:

Native American was somewhat inane.

Down's Syndrome, obesity, Liver issues, Nafld/Nash a problem. Different characteristics to gen pop., potentially different etiology , almost certainly effectively (if not explicitly) excluded from trials. Do they get excluded from using approved drugs? No. The label is open to that use, as will be the case for gen Nash drugs in Hiv and doctors will approach the issue with caution. It's just not the case that drug labels have long lists of conditions that the drug wasn't tested in, it has some specific ones like pregnant women and some where the drug is proven ineffective and some where there is a strong argument for exclusion if not empirical data or extra dangers but not a long list of untested scenarios and hiv is just one of many untested scenarios. It's up to the clinic and researchers and pharma to answer the 100's of questions that weren't asked in the clinical trial in the post-approval period and the label allows the space to ask those questions.

There won't be a regulatory hurdle stopping doctors trying gen Nash drugs in hiv patients, there will be a strong clinical rationale to try Egrifta first. That hopefully secures them a good market share , it doesn't give them exclusivity.

Hopefully Intercept will get their drug approved soon and we can see what the label looks like. That drug wasn't tested on hiv patients would you expect it to rule out the drugs use in hiv?

juniper88 wrote: In your hypothetical scenario where the native Americans specifically excluded and why?  If it just happened that none where in the trials then fine.  But the issue is that HIV+ patients are specically excluded.

 

qwerty22 wrote:

If a drug was never tested on native Americans in a clinical trial you don't block them from using the drug if it gets approved. The same is largely true in this case, I know we believe there is a significant difference between hiv Nash and non-hiv Nash but the evidence for that is not sufficiently strong to lead to exclusion on a drug label.

I agree that there will be a strong clinical rationale to use Egrifta in the hiv pop and that might lead to a very strong market share but that's not the same as exclusivity. The gen pop Nash drugs won't have a line on their label excluding use in hiv patients, there won't be a regulatory block for other drugs to be tried in hiv patients. It will all be about clinical practise. Independent studies or Ph4 trials might quickly prove/disprove effectiveness of gen pop drugs in the hiv pop. Because there will be no regulatory hurdle to overcome (other than getting the trial approved) then that data immediately begins to inform clinical practise.

I certainly believe the drug should be strongly placed to capture high market share in the hiv market but I don't believe there will be regulatory exclusivity or exclusivity from the payors, it might come de facto in clinical practise. Do we know that when faced with a diagnosis of NASH a doctor will say "I need to treat this NASH" or "I need to treat this NASH in an HIV setting"

 

juniper88 wrote: Of coure if HIV+ patients are excluded from the trials then those drugs should not be used on HIV+ people when those drugs come to market.  Those drugs might be safe to take but no efficacy has been proven for this group of people.  And that is the main objective of the trial. 



 

 

qwerty22 wrote:

I don't believe in this exclusivity argument. Many drug trials will exclude hiv+ people for many reasons. It doesn't then mean that hiv+ people are excluded from using those drugs when they come to market. The same will be true for treating NASH. Certainly the clinical rationale will be much higher to use EGRIFTA and many general NASH drugs may fail in hiv+ patients in the clinic but to talk about exclusivity is going too far in my opinion. What you would essentially be talking about is blocking hiv+ patients access to drugs, that doesn't happen. If there is a clinical rationale to not use a certain drug in hiv+ persons because it involves added dangers or evidence shows it doesn't work then yes restrict the use of that drug but you don't exclude because they were absent from the trials. 

 

longterm56 wrote: It's my understanding that a drug must be specifically approved for HIV NASH for it to be prescribed, and that THTX is *the only* company pursuing such approval.  So although the market may be 1/23 general NASH, Egrifta would be the first (and only for sometime) approved drug for HIV NASH.  This is why some of us hang around! 

Egrifta would requires an additional approval for general NASH, that's why it is not the main focus of the company right now, it would be an expensive pursuit. 

"seemingly sitting on a winning lottery ticket."? ... that's why I'm still here after watching this crash for the last two years.

   -LT 

 

 

Victura wrote: SPCEO1, thank you for your deep and involved analysis (it gave me a lot to go off and research!). Okay so let's look at the stock as a NASH play and compare it to NGM and MDGL as you suggested (although I'd say NGM is the best comparison by structure and operations).  HIV NASH as you've said is indeed a smaller market, representing about 1/23rd of NASH cases overall from what I'm seeing in the US.  Also the drug THTX is seeking NASH approval for looks to have an impact on lives fat reduction of 37% versus NGM's drug which produces a 58-67% drop (and MDGL's drug that produces a 64% drop).  We could look at market cap differentials like you stated to say that THTX should be entitled to a roughly 5.5x boost like you said (market cap of at least a billion as a NASH play) giving it a value of $10 a share by your analysis.  But with a market that is 1/23rd the size statistically of the markets these companies will serve, and a drug that is roughly half as effective, would you consider the possibility that these things are factored into the current price?  Also worth asking, since this drug will neither be the first to market or the most effective seemingly for NASH, are we just counting on HIV patients preferring it and paying much more for the specific usage with their condition?  Why wouldn't they chose something that has been on market longer that provides seemingly better results?  Have you considered the possibility that the market isn't unaware of THTX and its adventures in NASH, but just maybe that it doesn't consider them relevant?  I'm deeply interested to hear your response, as I'd genuinely like to believe your version of events where I am seemingly sitting on a winning lottery ticket.