RE:RE:RE:Financial and others You're not getting the important details on NASH. It was never the case the EMA would say a straight "No". You'd only get that with a hazardous safety signal. The EMA would always agree with something. What the company is announcing today is the EMA have agreed to a program that the company finds commercially unviable, the company is not prepared to activate. That's not a victory.
This program is shelved, that's the reality. They now have no plan to dose any patients. They have plans for a beautiful shining castle they are never going to build. We are now closer to the true value of this program which seems to be closer to zero. The analysts and the market got this right, there isn't a clear investable path to a Ph3.
scarlet1967 wrote:
On oncology reading between lines the trial is progressing well. On NASH they have completed the negotiations with both agencies and have EMA onboard. They need now to do an interim futility analysis on 400 of total 1100 patients for 18 months (75 to 100 HIV), post approval will include additional 1800 patients. So my take is the EMA wanted that interim analysis included in the trial process and the total patients increased for phase 3 from 900 to 1100 and post approval from 1100 to 1800 patients resulting in more costly trial. As a result the company would like to find a partner for the program. That would be the ideal situation not only it brings resources/credibility but de-risk the program. This could delay the launch of the trial.
They have about still 57 millions which is a positive surprise. The sales were not great but let's see what they have to say about sales going forward.
As predicted NASH is very much on the table and EMA is onboard, the reason for futility analysis might be to to get more biopsy confirmed fibrosis patients and most likely to convince EMA to accept their harmonized protocol.
The good stuff is EMA is onboard, they will looking to partner up for NASH, oncology is progressing well and they seem to have same amount of cash now as end of February. The bad stuff is more costly NASH and not unexpected less sales.
"Our Phase 1 clinical trial of TH1902 for the treatment of sortilin-expressing cancers progressed as planned during the quarter and we believe that we have developed a targeted peptide-drug conjugate that may potentially transform the way cancer is treated".
palinc2000 wrote: Disappointing sales and change of plans im Nash -start of Phase 3 Trial delayed and THTX looking for a partner in Nash due to higher Phase 3 costs