[Ed. Note: Dr. KSS writes for the Irregulars about medicine and biotech stocks. He chooses his own topics, and his words and opinions are his own. He has agreed to our trading restrictions.]
Tekmira (TKMR) shares have surged in response to announced use of its anti-Ebola RNAi therapeutic. Despite this, share action has occurred in the absence of insider or institutional share purchases. This may be a sucker’s rally for retail investors, and by my reckoning the company is here overvalued.
The FDA is behaving oddly about Tekmira’s Ebola agent: the IND-supported agent is on partial clinical hold, and yet Tekmira has made heavy weather about how both the FDA and Health Canada have “authorized” use of the agent on a compassionate release basis. While the FDA has a revanchist sense of eminent domain and would certainly tell you that Bulgarians should not be able to take aspirin without FDA approval for each dose, the fact is, FDA jurisdiction applies only to the US and its possessions. The FDA cannot “authorize” an agent made by a Canadian company to be used on patients in West Africa any more than it can authorize the sun to set. Somehow the FDA has both granted TKMR permission to use the drug but also keeps it on partial clinical hold, a luridly schizophrenic stance that implies different safety standards apply to Africans. The FDA is gimpy on RNAi policy because it is slow, behind, elephantine, and like the French Army always ready for the prior conflict but unable to handle things now.
Ebola’s virulence has gotten so attenuated during the summer that it now kills fewer than half of those who become infected with it. And this makes sense: we now know that Ebola is spreading person to person, and that the ongoing epidemic is not the result of natural reservoirs repeatedly passing virus to humans. The entire plague appears this time to have begun when a single “bush meat” animal passed it to a single human. All subsequent cases have, based on RNA sequence analysis, stemmed from that one human patient. Basic standard hygiene is all that’s needed to stop the epidemic.
Most Western physicians now accept that Ebola is the wrong entity to finger for the deaths in Africa. People are not expiring from cytopathic effects of the virus. They are dying of hypokalemia, of anemia, of ...
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