Theratechnologies Inc T.TH

What's Next?

[longterm56]

So ... are we sitting on a dead stock until *after* the FDA accepts their Phase 3 submission (~60 days after submission)?  The "opportunity cost" for me being in this stock the last 3 years is humongous! Stock market going up ... THTX going down.  I don't even want to do the math ... I know it would depress me. Please don't tell my wife!  

So is December/January really what we're waiting on?

  -LT

[1998novl]

Opportunity cost is easy to add up in hindsight. Just like you, I would have enjoyed owning Shopify, Coupa Software etc etc..., in being an owner of TH shares - it's exactly that, ownership.  Catalysts as I see them: 1) IND for SORT and NASH. 2) IV Slow push  3) Egrifta SV bounce back and continued momentum as I can only imagine patients will stay on this version longer 4

[longterm56]

Sorry, but another list of catalysts isn't helpful ... I've seen literally dozens of catalysts come and go over the last 3 years. Even an announcement of going for general NASH was met with a downturn?!?!?!  THINK ABOUT THAT!  A company announces that an existing drug can enter the general NASH market and no response?  None of your catalysts come close to that.   

[1998novl]

Ok, I'll make it simple; End of 2023! And if you wait 3 years to buy the stock - it may no longer exist! It's impossible to predict when the stock will move higher if that's what you're asking!

[SPCEO1]

While we all sympathize with Longterm's exhaustion over many catalysts coming thru but the stock price not reacting to them as it has been very frustrating for all, catalysts are still what is going to drive the stock price higher. So, here is my list to supplement 1998novl's. 1.) FDA/EMA approval of a phase III NASH trial. This is clearly the catalyst that should have the biggest impact

[palinc2000]

In para 2 Getting 48% instead of 38% has no impact on reported sales.Indeed THTX Trigarzo s sales revenue as reported represent 100% of Trogarzo s sales. The impact of 48% vs 38% has an impact on the bottom line and cash generation but not on sales

[mikeq113]

SPCEO, can I ask why you're expecting a January response from FDA/EMA? I was under the impression the IND submission was imminent ("within the next few weeks" was thrown around almost a month ago) meaning we'd be looking at a max of 30-60 days putting us mid to late December at the latest.  I was also hoping that after over a year of conversations with the FDA, EMA and

[SPCEO1]

Since TH is asking the FDA to do something out of the ordinary, I am assuming it will take longer to get it all sorted out. Just being conservative. It is possible they get a response before the end of the year.

[Wino115]

I don't know about the EMA, but for the FDA those are rough timelines.  I'm guessing given this new large wave of Covid in EMA they may also be rough guidelines.  I'm not sure you'll hear the actual day it's put in but I would guess in some future CC if someone asks, they'll say roughly when it went in and when they expect a response, with all the caveats of

[jfm1330]

My understanding of a phase IIb/III is that the patients in the IIb section count in the requiered number of patients in phase III. So less patients to trat in the phase III part. But you need to complet the phase IIb first, see the results, and if good enough, go ahead with the phase III part. So timewise, it would be much longer and to my knowledge, Thera is the only company proposing a protocol

[realitycheck4u]

This post has been removed in accordance with Community Policy

[scarlet1967]

They did issue PRs when Trogarzo's BLA were submitted to both FDA and EMA  so I would expect there will be a PR once Tesamorelin NASH application is submitted.

[scarlet1967]

https://www.theratech.com/wp-content/uploads/2019/09/nr-20170503-en-6.pdf