The failure of Tovaxin phase II study was disclosed in September 2008, so we're talking about almost two and a half years of repeated promises from Opexa's management.
Opexa issued a press release Wednesday announcing that it had completed two "successful" meetings with the FDA, which offered "positive feedback" about Tovaxin. Opexa now "believes" it can advance Tovaxin into a phase III study.
"Believes" is an interesting word in corporate legalese. It's a form of insurance, designed to insulate any CEO from liability if something goes wrong. For example, "We signed a contract believed to be worth $10 million" is a much different statement than "We signed a $10 million contract." As a biotech observer who focuses on fundamentals, I pay attention when a company relies too heavily on the word "believes."
Opexa states in the release: "Based on positive feedback from the FDA, Opexa
believes it is now positioned from a regulatory perspective to advance with a pivotal Phase 3 clinical study of Tovaxin in MS."
I read a statement like that and think: This is absolutely meaningless because FDA doesn't endorse or "approve" the start of phase III studies. Regulators only object if there are safety concerns or risks that may harm patients. Outside of that, companies are free to conduct phase III studies whether FDA thinks a drug is deserving or not.
The press release continues with a quote from Opexa CEO Neil Warma:
"We are very pleased with the outcome of our two recent FDA meetings regarding Tovaxin, the first ever personalized T-cell therapy for MS patients, as we
we now have a well defined path forward for Phase 3 clinical studies. Importantly, we
the outcome of these meetings will contribute positively to our ongoing discussions with potential development partners due to the importance of the FDA's feedback, as well as our ability to secure the necessary resources for the continued development of Tovaxin. We remain motivated to again treat patients in a clinical setting as we continue to
Tovaxin is the most promising therapy in development for MS."