RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:Piper Sandler Conf?Let's not forget the bullish point made many times here -- that so far the FDA and EMA are seeing compounds fall by the wayside as either completely ineffective (many) or not particularly safe given the patient condition (a few, and likely more as time goes by). The list grows of those in need of transplants, those with NAFLD moving into NASH and there's nothing out there. I'm not saying they would remotely lower trial standards -- that's just not the case. But with this failure and a growing medical issue, I would think a regulator would want to encourage a new approach with a different MOA from all the others just to add one more chance of success. The reason Warp Speed backed a half dozen or so approaches was to have a diversified approach hoping at least one or two would work. (I don't think they remotely believed we may actually see 4-6 work, but that's great). I'm of the belief they're looking at this similarly given the lack of success. Everyone thought there would be two approved drugs by end of 2020. There's zero and at least another year until one could show it works.
To approve another PPAR or FGF or Thyroid Agonist isn't diversifying the regulators pipeline at all. Adding the only growth hormone stimulator would achieve that. If they make it onerous by adding more time or money then they need to, it won't help that cause at all.
Let's hope Loomba, Grinspoon and the rest of that panel can convince the regulators of this.
qwerty22 wrote: That second point you get from your own intuition or your interpretation of noises made by the company? That's exciting to hear because it fits my own expectation ( nothing better than confirmation bias!). I think there's going to be value in that both for us and the company, and maybe it'll satisfy some of the analysts misgivings. I'm of the opinion once you've fully accounted for the weaknesses you can move on to the strengths, which there are many.
In very basic terms (that's about as good as it gets for me) it comes down to whether this is a clear two step process like Akero or whether it's rolled into a "seamless" process which ends up being not too far from a Ph3 in terms of time and cost. The excitement is in getting a good first look at what the approach can achieve in non-hiv patients, an interim analysis gets us to that point quicker.
SPCEO1 wrote: I have not had that conversation withher recently but she did note one time we spoke that she told TH before she joined that it takes a fair amount of time to build a good IR operation and that they should be prepared for a lot of spade work before reaping the fruits of those labors. And that is true. My hope is we will start seeing those benefits soon. If the FDA gets on board with what TH is trying to do in its NASH phase III trial, that should help a lot.
On the issue of the FDA's response to the proposed phase III trial protocol, my best guess is the FDA will want to see some of interim look at the data at a minimum to make sure things are proceeding as planned and that the possibility of a combined phase IIb/III trial being asked for is strong. How that is actually structured, if it is what the FDA insists upon, is what will matter. I would be surprised if the FDA just rubber stampled their proposed protocol.
qwerty22 wrote: It would be nice to test the proposition that they CAN build expectation. I think I could forgive them for doing it once! Haven't all the recent investor conferences been about building expectations?
Having said that I think you are about right, it's less common to announce that step, Maybe it happens more in going from pre-clinical to clinical, in some senses we are doing something similar in going from no program to a program.
I guess this means the cancer IND might already have been submitted if that didn't need the tweaking?
Maybe you didnt have this conservation with her but do you get the sense she's meeting her own expectations for the job from when she signed on for it?
SPCEO1 wrote: TH is adhering to the approach most drug company's take in not considering a submission of a trial protocol a material event. So, that is not an unusual approach. CYDY has the unusual approach of PR'ing everything almost to including when the CEO most recently trimmed his toenails!
The submission of the protocol is not a material event because it means nothing until the FDA/EMA say "proceed". When they get that good word, or if they get "desist" instead, that will be a material event. But I agree with your sentiment that in this particular case, a good argument can be made that this protocol submission is more material than most. My guess is we will get some indication at some point about its status just as we were told by the CEO last week that its submission was imminent.
One reason for not telling us when a protocol has been submitted (and this is true for all drug companies) is the company does not build up expectations they have to deal with later should the outcome not be favorable. In the case of TH with phase III NASH, however, there is no avoiding those expectations being built at this point.
scarlet1967 wrote: "She said if they put out some related PR maybe they would slide some mention of it into it but that they did not want to set a precedent for PR'ing a non-material piece of info like that. Basically, they don't want to become CYDY."
Why the submission is not a material event specially when there has been many doubts re validity of the program and delays?
They don't need to become CYDY but they certainly can show off the progress they are making including submission!
I would like to know how many companies out there would not inform their shareholders and other investors when they reach a milestone such as completion of a phase 3 application and submission of it?
This is not the way you promote your achievements and your business convincingly.
When does this public company understand they are one of hundreds and hundreds of companies investors can choose from so hiding your progress doesn't make sense if you want some attention.