Of note was that the MILO study was Binimetinib versus Chemo, NOT Binimetinib plus Chemo versus Chemo alone. It was active drug versus active drug, rather than a combination. So the read-through to other studies is limited. MEK inhibitors work. Because of trial design and previous phase 2 work I believe that the other studies for both Binimetinib and Selumetinib are more likely in to show positive results.
I agree with all these points, frank and others above. I would add that (if I remember correctly) because Provenge required sending a sample to be made into the vaccine, there were upfront costs and commitments while reimbursement lagged by perhaps months. This unappealing structure made Provenge even more of a boondoggle. Yet another Provenge issue that will not be present with Rintega.
Good points, value. I would add to this statement as follows: "if sapa = daco then would expect ~ 56 at 18 months, assuming the patient populations were comparable". (I realize this would be addressed by your caveat "All things equal") DACO-016 was in patients 65 and older; SEAMLESS is in patients 70 and older. How exactly this will push the curves is an unknown, but may tend to reduce survival times versus DACO-016 (including via the early high mortality rate you mentioned). As always, performance against the control will be the major arbiter. But yes, the possibility of a late separation and comparisons to DACO-016 are very interesting.
I do think that regional partnerships can be used to maximize the value of any program. For example, a deal could be signed for Japan and East Asia first. Alzheimer's and Parkinson's have a prevalence in Japan and Korea somewhat comparable to that in North America and the EU. The funds from a Japan+East Asia deal could help Prana build out it's development efforts and give them leverage in any deal for the EU and/or NA.
I suspect it would still be helpful to any non-US regional partnership negotiations to have the PCH lifted, as this would provide credibility/validation and boost the global value of the drug. There may be some leverage to be had there.
You're correct. Terms and conditions have to be carefully established to include
obligations to advance the drug or return rights. This should be obvious, but clearly this sometimes still becomes an issue.
But it should be through a partnership (at least at some point soon). I want the infrastructure. I have heard it said that whether you partner or sell shares to pay for the trials, you're diluting future earnings. But these are not equivalent actions. You're not just getting money upfront and milestones when you partner; you're getting regional or global infrastructure and experience to properly conduct trials, hopefully file for regulatory approval and then market the drug. I don't mean to overextend your comment or imply you were saying more than you were. I just wanted to take the opportunity to suggest that investors recognize that going-it-alone is often a bad idea, as appealing as keeping the whole pie may sound.. A partnership is often critical, even in situations where we might think a good drug will "sell itself". It can be the difference between keeping a healthy portion (say, 20%-30%) of a large pie versus keeping 100% rights to a pie that never gets baked.