Cantechhttps://www.cantechletter.com/2015/09/telesta-therapeutics-has-huge-upside-says-euro-pacifics-loe/
Yesterday, Telesta announced that it had received notice from the United States Food and Drug Administration that it had organized an advisory committee to review Telesta’s biologics license application (BLA) for MCNA. This advisory committee will be held on Wednesday, Nov. 18.
“This advisory committee is another critical step on our path toward potential approval of MCNA as the first new therapeutic for bladder cancer patients in decades,” said CEO Dr. Michael Berendt. “We will continue to work with the FDA and their advisory committee in exactly the same fashion as we have conducted ourselves over the last 18 months, with full transparency, candor and scientific rigour. We know that high-risk BCG-refractory and BCG-relapsing patients are in great need of a non-surgical option for bladder preservation and we believe that this is exactly what MCNA will provide.”
Loe says this is an important step for Telesta and says he rates the chance that the FDA would contradict recommendations by its appointed panels on the Buster Douglas/Rulon Gardner/Roberta Vinci scale, that is to say extremely low.
“The business risk inherent in the FDA Advisory Panel are no different than those inherent to the BLA itself, on which we have commented before and which bear significantly on our investment thesis,” said Loe. “Our model assumes that Telesta’s now-published (in Journal of Urology) 129-patient single-arm open-label pivotal Phase III BCG-refractory non-muscle-invasive bladder cancer (NMIBC) study was sufficiently robust, and demonstrated sufficiently significant disease-free survival, to justify recommending formal FDA approval.”
Quebec-based Telesta Therapeutics is an oncology biologics developer, with lead non-muscle invasive bladder cancer therapy, MCNA (Mycobacterium phlei Cell Wall-Nucleic Acid Complex) set for imminent BLA (Biologic License Application) Filing that Loe believes could lead to formal FDA review in the first quarter of 2016.
In a research update to clients today, Loe maintained his “Speculative Buy” rating and one year target price of $1.50 on Telesta Therapeutics, implying a return of 266% at the time of publication.