RE:RE:RE:Letter It's more a management consultant term around not bothering with future plans until you hit your decision point with positive data. Pass each gate first, then move on.
I think it points out they plan to enroll but will have clearer data points to move to next group if enrollees. Maybe points to having more informed prescreenjng around types, sort levels, pre-treatments, etc... Recall in the initial call notes it was stated they learned the checkpoint inhibitor pre-treated patients showed less efficacy and they theorized it affected the ability of taxol. So they theorized melanoma enrolled with past inhibitors were bad candidates.
I think that stage-gated language is around breaking the TH1902 concepts down to see if it can pass the stages and also not bothering with a lot of future lab development until this one goes through its stages and they see positive or negative data at the decision points. A way to high save money and address what you can methodically. Just my interpretation but they need to clarify it exactly.
The whole point is to get back to enrolling but with an informed protocol so I can't see them NOT enrolling to see if it improves.
qwerty22 wrote: "stage-gated"
Sounds like there's significant uncertainty about whether another patient will ever be injected with TH1902. They obviously have a strong desire to do it but seems like there's still some major decisions to make before that happens. It still lacks any clarification on how much efficacy they saw in the 1b patients they enrolled (Is there something to build on?).
On your question about other candidates we have to be realistic. They've published once, on one other version that isn't 1902 or 1904, that still falls into the cytotoxic category. Any other version is years away from the clinic. This won't be a short term saviour even if it turns out to be the chosen path and it coming on the back of 1902 failure will keep interest muted for longer.
Focus is now down to commercial assets, maybe hitting guidance was what they were waiting for to put out a message. It's curious they didn't detail cost-cutting maybe that comes with the next quarterly.
realitycheck4u wrote: Good letter from Paul. It reads like he talks so was good to feel it, and not just read it. I wish they could articulate some of the options with 1902 and how they can or will consider other candidates to use with it, but I assume we will hear about this soon enough. I think it was Fred or JFM who had some ideas around that. The only thing not in there is an expected timeframe for resubmission. But this was well played, just too late to stop the blowout of the share price. Could have had part of this news 3 weeks ago and followed up with more today.
Scioto wrote: Small step. But important. Need to build-up relationship brick by brick. Communication is critical.