IMV Inc IMVIF

Hmm. So, collaboration continues?

[alphaseeking001]

Hi all,

So... what the hell does this release mean this am?  Are there any Merck funds here??  Doesn't appear obvious that there is.  So little clarity.  Frustrating.  If anyone else can provide insight into today's release that would be great.  Thanks all.

[Breakthorough]

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

[Jthom376]

Looks like a flat year on stock price. 

[qwerty22]

I hate when biotech put out statements that seem to say something and nothing at the same time. So does 2) say "after this trial Merck will get serious (maybe)"???   Other things 3) no cash 4) no talk of registrational trial 5) with and without cyclophosphamide. Turns out the analyst was less dumb than some thought, you don't throw in an extra arm to a trial unless

[Breakthorough]

True. Anyway, in relation to Cyclophosphamyde they have to already know something, because of the comparison between the two ovarian cohorts in the Basket Trial. But they didn't eisclose data...

[qwerty22]

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

[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.

[Biotech010]

the trial is designed to get the accelarated approval. They need to repeat in a larger number of patients the data that they had in the PDL-1 positive patient population.  That is want they wanted to hear fromt the FDA and that's what they got. So if in Q1 2022 the interim results point to the same results.... jackpot.  For now, it's a waiting game. I expect Fred and his

[qwerty22]

Accelerated approval is (almost) always the case in cancer in these types of studies because it depends on surrogate endpoints, you shouldn't think this is some sort of special achievement by IMV.  This is not a registrational trial although it might expand into one so you're going to have to define what you mean by jackpot, this is probably the most disappointing aspect of the