RE:From unjustified optimism to unjustified pessimism I would suggest one major edit to your post. The optimism was not unjustified at all. The pre-clinical work was very strong. It led to the FDA granting Fast Track status before the first human had been injected. It also led cancer investing expert Soleus to become the largest shareholder in the stock. There were peer reviewed articles on TH-1902 which had favorable info. They were able to add Pfizer's recently retired as a scientific advisor, which was especially encouraging. Most small cancer companies would have traded their first born child to get Dr. Rothenberg as an advisor. In the phase 1a trial, they had one patient who saw one tumor eliminated and 53% overall tumor reduction, so it appeared the drug was working on some level. Just before the pause a new analyst published a thorough report where he included value for cancer - one had to believe he had done considerable due diligence with the CMO before publishing that report. So, the optimism seemed justifiable to me.
The current skepticism may be overdone but it is not fully unjustified. It is not easy to recover from such a setback and that recovery is made more challenging by financial constraints.
scarlet1967 wrote: “The mandate of this Scientific Advisory Committee is to optimize the protocol amendment for the development of TH1902.”
He said optimize not validate!
“Questions raised by the FDA were already being addressed by our team as part of our sub-analysis of the data accumulated so far, and we are confident that we will be able to address all of their questions. Finally, the FDA indicated that their review of the protocol amendment would be completed within thirty days of submission.”
To me it surely sound like they will go ahead with it.
So for those who are speculating about the validity of their approach and alternatives as a reminder not only experts have to design it but FDA has to approve it as it has to be convincing arguments that restarting the trial doesn’t harm the patients and has a logical reason why it can benefit patients.
We don’t have access to data in order to even hypothetically predict what is the rationale, the scientists performing sub analyses have.The company’s job is that the restarting of the trial is safe and worth the risk of allocating resources. If they say they have already address the questions asked by FDA and/or are confident they can address them and FDA already have said the amendment will be assessed within 30 days to me it means the decision to pursue with it has already been taken. At times the board has been over optimistic about this project and now in my opinion too pessimistic most likely because of skepticism. I believe they need to explain much more in detail about the protocol so investors can build an educated thesis. If the company is convinced about their approach convince the market to the best of your ability, this time the decision is based on data from humans so the presentation has to have the details from new findings. If they want to deal with skepticism about the future of the trial and the sort1 platform they need to share as much as possible details before the restart, they used/shared the preclinical data to validate the decision to start the trial now they are using human data, so they have to share the details with their investors so the market understands restating of the trial is a legitimate decision both scientifically and financially. I can’t emphasize enough how important a much improved communication about their operations is.