I am not a pumper or eternal optimist. I have so many shares, I have no choice but to wait it out. Interested in somewhat informed and honest opinions on what comes next. In my view, we definitely, of course, need a review of what happened. Don't want to dig into the past, its done, but insght-003 was the EXACT same regiment with apparent excellent results, so just utterly baffled on how this didn't pass the low bar of futility. A review might reveal a way to salvage lung cancer with another sub-group focused trial (but it would be a complete restart of a phase III, with all the expense). Also a chemo-free trial would only need to match SOC since the side-effects are so minimal. I think Merch forced the chemo inclusion. All that said, they have approval from the FDA to do a small (70-90 patients) single arm trial in head and neck PD-L1 negative group to get accelerated approval. If that small follow up is positive (just like the previous success in a small group, redo), AA means they can start selling the drug with insurance reimbursement. In other words revenue. That small trial would be a fraction of the cost of TACTI-004, so they have the cash for it. The follow up trial would need to confirm the results, but the full randomized follow up would take a bit (all while having sales). I would think this might be the fastest path to recover. But they will need Merck participation, is that under question now? I don't know. Hopefully in the next week or so we see an explanation and a direction forward. Also, I haven't looked but will, does the Dr. Reddy agreement cover all efti sales in their region or only for NSCLC (I suspect all sales). There may be milestone payments tied then to success in Head and Neck too. I will leave IMP761 out for now, its too early. Reasoned un-emotional, non-political, at least somewhat informed, thoughts please.
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