RE:RE:RE:RE:RE:RE:RE:RE:RE:RE:I have complaintsGenerally blood tumor markers go up with progression for those patients sensitive to it, not all are. But it is not proof because tumor markers can go up or down for other reasons. Although most of the time it is pretty accurate in predicting progession or regression. In my opinion, Paul should never have said those words without expounding on them. And the analysts should have followed up on that.
qwerty22 wrote: We are looking to get an impression of the therapeutic window. We can't get that without a sense of both safety and efficacy so I'm with you, not yet excited (if that's true then no reason to believe the market should be excited either). You make interesting points, hints of efficacy can come in many forms. If the insiders see those hints and it gives them re-assurance then why not share that with the market and let us decide on it's value. Something is better than nothing, we still have nothing on efficacy. It's very easy to caveat all this by saying it's super early and we expect later updates to add to the story.
I'll go back to what I said earlier. The CC update tells us they seemingly have a "safe space" in which to explore efficacy. If they had given us more we could say more.
juniper88 wrote: When my wife start a new chemo in January we right away saw her tumor marker go down. The oncologist did not want to tell us that the medicine was working because it needs to be confirmed by a CT Scan, which you don't want to do that often because you don't want to over expose the patient to radiation. I am not sure how ofter a CT Scan is done in a Phase I clinical trial setting.
So, a tumor marker can be an efficacy signal but it needs to be confirmed. Also, partial response, from my understanding is tumor shrinkage of greater than 30% but less than 100%. They might have seen less than 30% shrinkage in some patients and don't really want to talk about it yet.
Anyway, the point is that there might have been some of those signals but you really need to see what develops over time. Still, see those signals could make someone "extremely excited". Safety alone is nice but wouldn't make me "extremely excited". In fact, if we see safety only and no efficacy signals I would be rather dissappointed.
qwerty22 wrote: I don't mind reading tea leaves as long as we know that it what we are doing.
I might be wrong but my general expectation is efficacy develops over time and the reality is we are still early in the process. So not having something to say on efficacy is acceptable at this point.
Paul again said things are directionally correct (he said it about NASH). I read that statement to mean there's no need to panic (yet). They updated safety and generally what they said fits with safety being "directionally" fine. If they had said anything around efficacy, even just patients experiencing some stability for now then I'd probably be happy to extend directionally correct to cover efficacy. They didn't say anything on efficacy so I'm not letting directionally correct cover efficacy for now. None of this rules out the possibility of getting some efficacy by the end of the year.
I just don't believe they have anything meaningful yet because I think that would have been in the update.
PWIB123 wrote: I don't see a do-nothing approach as reasonable in spite of waiting on confirmation of certain milestones. There is a balance here. Your scientific perspective certainly keeps the scenario grounded in reality, but there's no risk-reward scenario in waiting for guaranteed outcomes. And thus, we must speculate! I personally highly value the reading of the tea leaves.