CEL-SCI Corporation (AMEX:CVM): The around-the-world approval announcements for the Multikine Phase III trial last week as the company issued a press release stating that approval to begin enrollment had been authorized by the Indian medical regulatory agency.
India, according to the press release, has the highest number of cases of head and neck cancer than anywhere else in the world, so Cel-Sci expects that patient enrollment in that country will come at a pace much quicker than what would be expected in the United States.
The approximately 15 sites that will enroll patients in India also bodes well for approval over there, although it may not be a wise assumption to bank too much on the Multikine potential in India, where poverty and corruption rule the day — much more than anything else.
There has been just one site approval announced within the United States for Cel-Sci, that being in Mississippi, but it’s unknown at this time how many enrollments in the trial have taken place. Some investors are still wary about the path that Cel-Sci has taken, in terms emphasizing the trial overseas, when the focus should be on US approval — and that might also mean focus on US enrollment.
Cel-Sci spends the time and money to issue press releases rebuffing Internet rumors, but it’s my opinion that a positive update on enrollment would win the PR battle a lot better than a ‘Letter to Shareholders’ would; the fact that we have not seen any enrollment numbers will have legitimate investors more sceptical than Internet rumors do.
That said, the risk/reward behind Multikine is huge. There are some big names attached to the trial, and the mark left by Dendreon (NASDAQ:DNDN) on the market after Provenge announced Phase III results was near historic, so this is a story worth watching.
The India connection won’t be what makes Multikine, but it’s another in a long line of site approvals announced by the company.
Disclosure: Long CVM
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