RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Just how Massive is this News? I'm not discounting anything you say here, I heard what you heard a company heading for Ph3, THEN I read the guidance document and I think that says late Ph2.
1) Maybe I mis-understand the guidance doc but all past decisions with NASH companies seem to fit nicely with my understanding.
2) Maybe I misunderstand what was said yesterday but it seems to be close to what you heard.
Do you accept my basic idea??? If you read the guidance doc (ignoring yesterday) that says we are a late-stage Ph2. Yesterday (ignoring the guidance) the company says we're heading for Ph3. There is a disconnect there?
The company didn't explain what they have that specifically resolves that problem. I can understand why the RBC guy is stuck thinking THTX need more data, I'm stuck at the same point. Maybe we are the two stup1d guys in the room. Rather than making judgement calls on what Ph they are at I probably should be looking for that piece of info that resolves this conundrum. I can see that info might look like putting words in the mouth of the regulator and would be tricky to spell out so maybe it remains elusive until the approval process is over.
Everything you say makes sense. It would be crazy for them to double-down on Ph3 if it's less plausible now. Too crazy.
SPCEO1 wrote: Do you thinik it is possible that TH would have had that press release and conference call yesterday without a good understanding about this with the FDA already? That seems improbable and would be way out of character for TH. Also, would Dr. Loomba put his reputation on the line like that if this was not already an issue that has been resolved? I suspect not. It is hard for me to think that Grinspoon, Loomba and TH management would have left that kind of issue unresolve before yesterday's presentation. That just does not add up.
Perhaps the FDA is fudging their process somewhat (the materials you quoted from Dr. Loomba likely had a big input into - indeed he may have actually written them) to let TH proceed to phase III and, if so, you can understand why the company may not want to say that in public.
The doctors pointed out the biology made sense and it is also hard for me to believe that the FDA would just ignore the very good results (and safe results) Egrifta has had over a number of studies in NAFLD/NASH in HIV patients. They are, after all, believed to be harder to treat than the general NASH population and I doubt they view them as worthless when considering the general NASH phase III.
One thing to consider, however, is even if the FDA does not have an issue with what you have pointed out, will TH's competitors in NASH be all over the FDA telling them they can't let TH move forward without a phase II in general NASH. That could be a risk. Even if TH thinks they have an understanding with the FDA about this, the FDA could come under outside pressure and reverse itself.
In the end, the risk will not be totally eliminated until the protocol is accepted. But my strong impression is there is very little risk of that. It would be a spectacular fail if that happened and Paul's tenure as CEO would have gotten off to a horrible start if things develop badly on the FDA front after the presentation yesterday. I doubt Paul is that much of a risk taker and suspect all will be well.
qwerty22 wrote: "not going to be fussed" about what is both regulators best (and it seems only) measure of efficacy. There needs to be a stronger argument than that!
The lack of patient data was brought up AND not actually answered by the company, the two docs had a go. If this is the stumbling block for the analysts then there has to be a solid, fact based response that resolves it, the company hasn't provided that. The guidance calls for biopsy data, the company mostly doesn't have it, that not just a minor inconvenience that's stopped other companies moving to Ph3, SPECIFICALLY (solid material facts) what does THTX have that gets them past that roadblock? I don't think it's a case of the problem being overblown, the issue is the analyst don't have sufficient information to move beyond that roadblock, the company hasn't provided it.
In my view there is clear distance between where the guidance document says the program is, and where the company says it is, the assumption is that problem has been resolved during the long interaction between the company and regulators, the company hasn't cleared explained how it was resolved so it's totally reasonable that the analysts hold on to that issue.
What you say about Loomba is reassuring though.
SPCEO1 wrote: Dr. Loomba was the most important part of the call yesterday. Apparently, he played a big role in advising the FDA about the NASH testing guidelines which the FDA put out. If Dr. Loomba says Egrifta is a logical candidate for pahse III, the FDA will certainly be listening to that. Moreover, the company has protrayed its discussions with the FDA as positive all the way along. My impression is the FDA suggested they go for general NASH since the FDA was not going to give them any special allowances to test in the HIV population.
On the size of the trial, MDGL is at 900 patients but they have two 300 patient drug arms and the 300 patient placebo arm. TH's trial has one 300 patient drug arm and the 300 patient placebo arm plus the 50 patient HIV arm. So, TH is not doing a smaller trial in the sense that the size of the various arms of the trial are the same as MDGL's.
There is no question regarding the endponts as THis using the endpoinits the FDA requires. So that is not even an issue at all.
The lack of general NASH patient data is the most relevant question brought up by the analysts but the company does not think that merits any concern. My impression is since Dr. Loomba and others agree the biology makes sense that the FDA is not going to be fussed about that at all. And given the safety of Egrifta and its proven efficacy in HIV NASH patients which are likely more difficult to treat, why should the FDA be overly concerned about it. Given the FDA suggested the company consider doing a general NASH study, I think that worry is overblown.
Wino115 wrote: Pray tell SPCeo, what exactly did you learn to give you such confidence that what they are filing within the next few weeks is a more or less agreed upon protocol based on the 12 months of back and forth? You seem very confident that it's just a rubber stamp from both EMA/FDA and we are off to the races in 2021 with a full P3 trial that hopefully can reach it's endpoints and provide the 10% differential and power to prove up the efficacy of tesamorelin as a real metabolic powerhouse for the liver. So you have no questions about size (650), endpoints, lack of Phase 2 on full NASH set, etc... all the stuff the analysts brought up. Sounds like none of them spoke to the company in detail after the call.
SPCEO1 wrote: Given what I heard today and previously, I cannot see how there can be a strong case to be made that TH will not be proceeding with a phase III trial. Yes, there are boxes to yet be checked but investors can pretty confidently move forward with the fact that TH is a phase III general NASH player as checkign those boxes will be relatively easy. The hard work has already been done.
longterm56 wrote: NO!!! Please don't say "more waiting". I was convinced that the "next announcement" would be the trigger ... I can't stand anymore waiting!!!
-LT
qwerty22 wrote: <snip>
Today has been a huge revelation but in many ways I still think we are where we've been for a long time, waiting for the regulators to approve a Ph3 trial. When (if) that happens then the unusual way this program has come about will become less important and maybe the focus can shift to the value.
Wino115 wrote: Maybe. I'm not counting on much love there. I heard Leno at NatBkCan wrote and had a bunch of issues that he could have easily cleared up with a call to mgmt which he clearly must not have done. Questioned whether FDA will make them do more work on non-HIV to get that data prior to a trial, thinks they'll ask for more than the 650 proposed, etc... In other words, he thinks the last year of consultation they've been having was done without any input from regulators. My reading is that they were pushed in this direction specifically by the regulators and in doing so worked with them on what it should look like. In other words, there should be no surprises in their submission in a few weeks time and it will include everything the regulators wanted and told them they wanted in the back and forth over the last half a year. Leno's been a sleep at the wheel for a while now. He should be embarrased saying things like that in an actual research paper. Easy questions that could have been answered in a 15 minute phone call with management instead of publishing what appear to be incorrect facts.
1998novl wrote: Thanks Wino nice work here. I'm most interested on the response from the RBC Analyst. He asked some good questions today and seems very interested- maybe he'll change his tune towards patents and give NASH some kind of value?