Thoughts after listening to today's conference?1) There seemed to be a herd mentallity amongst the committee members. Right off the bat there seemed to be a lack of objectivity when evaluating the drug.
2) Telesta's people really dropped the ball in terms of being able to answer questions be proposed to them. Unprepared is a word that comes to my mind.
3) US revenue was estimated to be 50% of global sales; we still have an opportunity for ex-US approval, and at current prices the stock is cheap compared to those sales estimates
4) The FDA usually follows the advisory committees recommendation when it comes to approving drugs; however in the case of Valstar the FDA approved it three months latet despite of a majority "no vote" by the advisory committee.
5) If the voting question included "for patients who refused bladder removal or patients who were not eligible to receive bladder removal" I wonder how much differently the outcome would have been.
6) I wonder how much of this no vote was influenced by all of the scrutiny being placed on the pharmaceutical industry by democrats. Perhaps they are feeling pressure to vote against drugs to show that they are "fighting back".
Just my take. A disappointing day to say the least.