RE:RE:RE:RE:RE:RE:No SP reaction to TH1902 good newsThere is a lot left to learn about TH-1902. The 1a was simply a dose escalation trial and was not aiming to solve all the questions around the drug. As the trials move forward, more questions will be answered.
On our call with management, they indicated that the 1a data dump was all the info they had on the 1a. So, we got what they have. Now, I know they have more nuanced info that we would all like to hear about but that was what they said.
Also, I asked if the two patients who had rolled from the 1a into the 1b were still in the 1b but they said they did not feel they could share that info. If they are still in the 1b, then there is a possibility we hear about a preliminary sign of efficacy soon. If not, then the August/September time f rame should give us multiple opportunities to ehar about that. Now, they also backtracked on whether asingle sign of preliminary efficacy is still going to be deemed a material event. So, perhaps we will not hear that even if it occurs and will have to wait until they have enough evidence for one cancer type to approach the FDA about a 1b protocol amendment. I am assuming they would choose the cancer they want to proceed forward with if they have multiple options and then not look for other protocol amendments for other types of cancer but I really don't know.
In any event, following our call, what I can be sure of is there will be a PR regarding a protocol amendment if the data justifies it and that is a big step in the discovery/approval process if it occures.
LouisW wrote:
In 1a, the result is good. But they need to know why some patient responded to Th1902, why others did not. Then based on the result to define criteria to select patient for the larger trial.....to select patient only based on 300 patients staining data is not sufficient at all.