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Random Divagations Around Cel-SCI (CVM)

|About: CEL-SCI Corporation (CVM), Includes: MRK
Summary

Market Cap 1/3 of a Billion : only ?

IDMC is reviewing 96% of the data.

Buyout.

Market cap

Yesterday Sept 27th 2019, Cel SCI (CVM) reached the 334 M market cap, that’s almost exactly One Third of the Billion.

That’s a lot, but that’s not much. What is the potential for this company valuation based on sole Multikine ? Conservatively, between 5 to 15 Billions $ (read this article). No doubt it will be integrated to Standard of Care if successful, median overall survival being at least improved of  28 months from Standard of Care (Keytruda = 3 months on metastatic). If successful.

So , a 1/3rd of a billion bet could lead to a “Good 5 billions Spec”.

But is a potential x 15 a “Good Spec” ???

Indeed, but still I think that a x 5 would be a Good Spec as well, in particular given the fact that I believe it has at least a 50% chance of being successful.Indeed, 3/3rd of a billion is a good spec, prior any results. But CVM needs a bit of exposure. Thanks to Cramer  /UncleJay and people like this, Cel SCI  begins to have quite the required exposure.

1 billion MCap prior any results is possible, but not a given.

IDMC- Early stop of trial

Trial is calibrated to be statistically significant and powerful enough with the 298th event, meaning that they would have at least 95% certainty (p value or "significance") on futility and at least 80% certainty on efficacy (1-beta value or "Power") with the 298th event on the Kaplan Meier analysis by the trial protocol design.

If you prove 35% superiority with 79% certainty, it’s not enough. You need 80% certainty. Reversely, if you prove futility with 90% chance, it is not enough. “At least” being the key word in here, could it end earlier ? One need to know that every 10 events, 2% of the power of the trial is lost.We recently highlighted that current count of events should be of 286, 12 events away from the target. This would mean that the significance and/or power of current data would need to be tremendous VS the initial design to counterbalance the lack of data.

While this is possible (we have seen SEER SoC survival data is really worse than protocol assumptions), it will not be a given.

Possible, but not a given.

Buyout

My belief is that, if efficacy is proven either by the IDMC or by the final data readout, Cel-Sci will receive offers, many offers, by the millisecond it communicates the outcome to a third party.The trial is conducted under the gold standard of clinical trials : Overall Survival.

If efficacy is proven, no doubt it will be integrated to Standard of Care. No doubt based on this rock solid proof of efficacy, the overall potential profitability of the compound will be obvious for the big pharma. Obvious for Oral Cavity cancer, but obvious also for any kind of solid tumor. If successful, this will be a game changer : think that the median survival time (time when half the patients are expected to be alive) might be improved by several years  ! Only big Pharmas will have the industrial, marketing, monetary power to make the best of this compound for the patients, for their own profitability.

The price tag for Cel-SCI will be huge: the 5B$ mark has been mentioned, I would rather think of a multiple.

If successful, a given

Disclosure: I am/we are long CVM.

Additional disclosure: Not WUID