Post by
beechguy on Dec 03, 2015 7:38pm
Seeking Alpha
With retooling of the indication to elicit a more favorable risk-benefit profile and/or a black box warning, I believe this drug can win FDA approval. I base this belief on the fact that most urologists on the board favored approval, while some board members stated they would opt for approval if the indication were narrowed to patients who could not/would not undergo cystectomy [10, 11]. In my opinion, the benefit outweighs the risk, given the niche market and the seemingly enthusiastic guidance from the FDA on page 45 regarding utilization of this drug in a certain patient subpopulation [12]. Consequently, I remain cautiously bullish on this company. Notwithstanding my optimistic navet, I believe the stock's battering after the ADCOM decision on November 16, 2015 has afforded a good buying opportunity. From the period November 17 to November 19, the stock lost almost 75% of its value. However, from November 25 to November 30, it has doubled, and now trades at $0.27. I suspect this recent rally to be a result of "fear wane," whereby investors are again focusing on the long term, despite the setback. From a strategic perspective, this small pharmaceutical has completed a Phase 3 clinical trial and is trading far below even a single dollar. To underscore this, note that Telesta has already signed a contract with Ipsen, which includes a $10 million upfront payment to market the drug throughout most of the remainder of the world [13]. To me, Telesta is the epitome of undervaluation, especially considering its product can still make it to most other patients on the planet! However, don't discount the company's chances in the United States. Coupled with a first quarter financial statement of roughly $40 million in cash and liquid securities, and a burn rate of $1.3 million per month, and you see there is plenty of time to elbow into the US market (amounts in Canadian Dollars) [14]. Perhaps another, larger enterprising pharmaceutical is scrutinizing this fascinoma too?
Comment by
Frogger2 on Dec 04, 2015 11:18am
Once again a totally unrelated response. It's a article with opinion, it has no relation to who attended the Adcom. Ignore
Comment by
DamnYankees on Dec 04, 2015 11:40am
Thank You for the ignore Frogger, Fortunately you were not the intended recipient. My post was a general commentary on the effort here to deflect balme away from what happened at the Adcomm debacle, and subsequent elimination of 70% of shareholder equity in Telesta Therapeutics. Keep on trucking Frogger!