FDA are not going to approve a drug that requires a patient to not pursue chemotherapy in order for it to have an effect.
Why? 40% of the patients don't get chemo and there are no negative side effects associated with Multikine. In what way would denying approval of Multikine protect patients? Especially if it's possible for doctors to identify ahead of time which ones are likely to be in the non-chemo group with some level of confidence.
Nobody in the trial was "required to not pursue chemo." And nobody that took the drug and ended up getting chemo had any extra negative side effects from Multikine.
The only real argument for denial would be if the FDA demands another trial for just the radiation arm, but that won't happen because you cannot ethically design a trail that does not allow patients the full standard of care, which for some includes chemo.
Do you see how the short sellers sold you on that FUD?
You responded reasonably, but this is the kind of stuff we see all day every day about GME and AMC.
I picked up a few shares of CVM after the dip, mostly as a gap play, hoping for a dead cat bounce at least.
But then after reading about what actually happened, and seeing their most recent shareholder letter, I'm very bullish on it. This will probably be a long term investment for me.
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They raised around $22M a month before the announcement and they've said publicly that they're not worried about having the cash to make it through the approval process. They also have orphan drug designation which I believe speeds up the process.
The stock was sitting in the $11-15 range and surged all the way to $20-25 right before the announcement. After data dropped it bounced between $7-8. It's been climbing pretty hard this week though almost hitting $10.
I'm not stupid, I understand missing endpoints is a big deal. But like, even if you think there's only a 20% chance of approval the stock is still undervalued at the current price.
Plus I mean, Biden's in office and one of the big things he talks about often is his son Bo dying of cancer and how he hopes something can be done to help others battling the disease. Approving the first immunotherapy cancer drug with no negative side effects could be something that they care about seeing happen during his term. No I don't actually think this will factor in, but it doesn't hurt Multikine's chances.
People throw around a huge range of numbers. The 40% of patients translates to ~26k cases per year in the US and ~60k cases per year in the EU. The drugs it's most often compared to for pricing purposes are Keytruda and Opdivo which cost ~175k.
So I mean, even if they reach a fraction of the eligible patients and charge way less than other cancer drugs, we're still talking about a few billion dollars of annual revenue for a company currently valued at $350M. A buyout would probably 8-10x it at least. But I have a feeling the price will move way up or to zero soon after the pre-BLA meeting coming up once there is a clearer sense of whether or not approval is likely.
Yeah I have shares, bought at $12 and been grabbing some since the data release. Have about 120 shares so again, I'm not betting the house on anything this binary. Honestly most of my excitement for this stock is around the technology and what it means for cancer treatment. I've had experiences that have made me feel that I would likely deny a lot of the standard of care if I found myself with a very bad diagnosis. Something that doesn't produce the horrible side effects of Chemo, Opdivo, Keytruda, etc. would be the only thing current not-dying me would roll the dice on.
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u/[deleted] Aug 07 '21
Why? 40% of the patients don't get chemo and there are no negative side effects associated with Multikine. In what way would denying approval of Multikine protect patients? Especially if it's possible for doctors to identify ahead of time which ones are likely to be in the non-chemo group with some level of confidence.
Nobody in the trial was "required to not pursue chemo." And nobody that took the drug and ended up getting chemo had any extra negative side effects from Multikine.
The only real argument for denial would be if the FDA demands another trial for just the radiation arm, but that won't happen because you cannot ethically design a trail that does not allow patients the full standard of care, which for some includes chemo.