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RE:RE:RE:Hmm. So, collaboration continues?

[qwerty22]

So they aren't even just focusing on PD-L1 positive patients at this point. It really is just a continuation of Spirel with a few extra arms to clarify the role of the components of the combo.

qwerty22 wrote:

I want to better understand the nuances of the trial design, do you have any thoughts? I took a quick look at what Simon's two stage design means. It seems it's typically seen as a Ph2a trial, as you say designed to clarify a previous result. Looks like there will be a mid point decision on the data to decide if the trial is stopped or continues (the two-stage aspect), in essence that seems like a good thing in that we get to a milestone as early as possible.

One thing I'm struggling with is why there isn't a Keytruda+cyclo arm. If you wanted to know whether dpx was doing something in this combo you would put Key+cyclo+dpx up against Key+cyclo and hope to see the first gives much better outcomes than the 2nd. To me that seems like the ultimate test of whether dpx is doing something in this combo. I must be wrong in someway about this, why is that arm not necessary?

 

Breakthorough wrote: It looks like a continuation of Spirel for clarification, including an arm without cyclophosphamide and snd arm with DPX alone. Apart, the only two positive statement (no money involved) are: 1) "Patient population and clinical endpoints aligned with FDA guidance for potential path to accelerated approval." 2) "In this collaboration we look forward to collaborating with Merck, beyond the provision of Keytruda, to ensure clinical and regulatory alignment, thus optimizing our probability of success."