TCDA Update

Ninerfan80 posted a question that I think should have its own title. Ninerfan wanted to know my take on the FDA rejection of the New Drug Application.

The FDA said that it has a problem with labeling and marketing, so it won’t approve the New Drug Application at this time. That’s not good news, but it might not be catastrophic. The FDA did not announce any concerns with efficacy or manufacture of Veverimer, the only drug candidate to treat acid build up for chronic kidney disease patients, a large indication.

Because there is a good possibility acceptable label and marketing language could be sorted out quickly, I am holding steady. Depending on what the problem is it could be easily fixable or it could be a big problem. There’s no information on this yet. My GUESS is that this will be rapidly sorted out. I am debating whether to increase my investment by a small amount.

This is a speculative situation.

Good luck to longs. Apologies to all. I am traveling so I am tardy with this.




To be clear, FDA did not reject the application nor did they (yet) delay it. They sent TCDA a letter, most likely a Discipline Review (DR) letter. In this setting a letter coming from a specific review section (discipline) of the application, not the voting advisory committee. The letter did not specify what the concerns were. This would suggest that they did not get an action letter (AR) which would require action on a specific issue prior to review. ARs are always very specific.

So my best guess would be in line with Bulwnkl; that is, it gets sorted out before the Aug 22 review date.

Cosmid (long TCDA)