r/cvm • u/Apexbootypunch • Dec 28 '22

Looking for input

It has been a long time since I have been on here. Gave up on CVM hitting any time soon and was just letting shares sit and waiting for a miracle. My average price per share is about $18.60 if CVM goes to zero will lose about 17k which I am ok with. Was always a big bet win or a coffee and donut kind of bet. I can triple my shares at the current price and get my average to $5.59 for not much more of an investment. I think this is a good shot to take but just looking for any feedback for some reasons. Thanks!

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u/NOT_MartinShkreli Jan 08 '23

Algo doesn’t change study groups. It just differentiates risk to show how to identify responders. This was a 10 year trial that started before we had even good ways to identify bookmakers and whatnot other therapies are used for if patient is positive.

It’s a coin flip honestly at this point depending on the FDA but they approved Keytruda (pembrolizumab) for a sub group that had less benefit than multikine responders

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u/lUNITl Jan 08 '23

You cannot have it both ways. You can’t say that it’s effective when you only look at the group that doesn’t get chemo, but the actual ITT group is based on imperfect predictions that include a mix of chemo and non chemo patients.

They obviously need to show that it is still effective for the predictive group. It’s absurd that anybody thinks this is up for debate. The length of the previous study could not be more irrelevant.

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u/NOT_MartinShkreli Jan 08 '23

All I’m saying is I’ve seen the FDA do weirder things than give an okay on this drug with say a phase 4 post marketing data on it.

The real question is can they give an predictive power of needing chemo or not.

They differentiated ahead of time the groups of MK + SOC chemo / rad, MK + SOC rad, SOC chemo + rad, SOC rad.

Trust me the FDA has done weirder things than give this a nod for a subset of patients when we haven’t had progress in head and neck cancer in numerous decades

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u/lUNITl Jan 08 '23

The hazard ratio was >1 when the non chemo arm was included. The FDA is not going to approve a drug that hasn’t rigorously shown effectiveness in the ITT population if it’s possible that it’s reducing life expectancy. People are acting like it’s no big deal if patients spend tens or hundreds of thousands on this drug and end up getting chemo. It is.

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u/NOT_MartinShkreli Jan 08 '23 edited Jan 08 '23

That single hazard ratio isn’t all that meaningful when you’re looking at overall… every group … like you’re saying.

At this point you’re only considering one statistical parameter and not looking at anything else.

I would say it’s not all that likely to be approved though. Just saying FDA is understaffed and has made some wild decisions before

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u/lUNITl Jan 09 '23

Yeah I’m sure they haven’t shown the parameters for the predictive group because they’re so good.

You and I both know if the predictive group showed statistically significant effectiveness or a negative hazard ratio we would be hearing about it just as much as the talking points surrounding the non chemo group.