RE:RE:RE:RE:Not surprisingTH is saying it is all about efficacy not being adequate, less about safety. IF safety was the issue, Isuspect they just would ahve shut the whole thing down. They don't talk about enrollemnt so you can safely assume it is pretty awful. And it is likely pretty awful because not enough efficacy was seen so far so clinics were opting to put patients in other trials. I can imagine a situation where Paul was beating on Christian to get enrollment going, Christian was leaning on the clinics to get going and the clinics were responding they had not seen enough efficacy signals to refer to patients to TH's trial. Eventually, reality wins. The safety issues would likely not have been an issue of much consequence if there was sufficient efficacy being seen. I suspect they were seeing a lot of minimal efficacy such as two of the three patients in the 1a with stable disease saw and they wanted and needed more than that. Will the tinkering lead to better results? Maybe, but we know that if they did not tinker the trial would be a failure as the clinics were not likely to enroll many people if stable disease was the best outcome. So, while the score is ugly and time is running out, there is still a chance. Less of a chance than previously, naturally, but it is not zero. Apparently another peptide drug conjugate made similiar changes and it then worked, so maybe there is hope.
I noted the risks were growing once we got past mid-October with no updates. More recently, however, I was leaning towards maybe they do have something positive going on in the trial (Why hire the oncology regulatory affairs person if the trial is about to shut down? Why allow the Jones analyst to publish his cancer focused research report if two days later you pause the trial?). But the reality was the drug was not working well enough to justify continuing and the clinics likely were no longer recruiting patients for the trial.
qwerty22 wrote: Colour me sceptical.
So they are prepared to add a couple of years to this program rather than run this small trial 3 more months and see what comes from the last couple of enrolled patients? They aren't being forced to make this huge decision by safety, It's just a matter of efficacy fizzling out? The bar is pretty low for efficacy success at 2/10 responders. If they don't believe they can hit that at this stage then unconvincing efficacy must actually mean no efficacy. Is tinkering with the protocol a solution to that?
I can see them, on a phone call, spinning a terrible safety signal as something they could live with if efficacy was better, as long as they didn't reveal the magnitude of either. After all you have approved drug with "may cause death" as a side effect so that is always going to be potentially true no matter how bad the safety signal. Doesn't mean it wasn't safety that actually triggered this decision.
Where are we on enrolment? If it was going well there's two or three to enroll. If it's going slow then maybe upto 5. That might not sound like many from which to pull a responder but then 10 was never a very large number either. If they aren't being 'forced' to stop this by safety then I see no great harm in running this another few months to see what the full cohort tells you. It just sounds like a big decision to stop the trial and a relative small reason and solution. It doesn't add up.
Either safety is ugly or efficacy is diabolical or both. If this is the World Cup then they are 0-2 down with 5 mins of extra time to play. The chance they stay in the competition look awful.
SPCEO1 wrote: I know everyone is distressed by the news on TH-1902 but the legacy drugs continue to sell well and if that continues and they get the one filing done, TH will actually be getting more money from Marathon in June 2023 to complete the financing of the convert redemption. The agreement for that to happen is already in place.
So far I have seen analyst reports from Jones, Cantor and Research Capital. All have maintained their Buy ratings and target prices, even Jones where a significant part of the target price was made up from TH-1902 future values. Jones was the only analyst who gave any value for TH-1902. These reports also indicate the issue was more efficacy being too mild and not really a side-effect problem. Apparently, a 100mg dose given almost weekly is being considered.
TH-1902 is not dead but it is delayed. That is unfortunate but not an existential crisis. The stock's sell-off is overdone given the value of the legacy drugs. Trading volume so faris lighter than I expected given the news, so that is promising. Sellng at these prices certainly seems like a sub-optimal reaction.
jeffm34 wrote: TH isn't even that anymore. Marathon Asset Management owns the legacy drugs when TH defaults
Momo25 wrote:
tH is now clearly a company of legacy drug, not more. No one will put a penny on the Nash program neither.