TELESTA THERAPEUTICS INC T.TST

Valstar Adcom Votes in 1998: 11 No, 0 Yes, 1 Abstain

[SteveMcM1]

https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20892_medr_P1.pdf

^See page 3, paragraph one for details surrounding the initial advisory committee vote for Valstar.

Many of you likely are aware that the only treatment approved for BCG-refractory NMI bladder cancer is Valstar, which was approved in 1998. Many of you are also aware, that similar to Telesta's MCNA, upon initial review the advisory committee voted against approving Valstar which went on to recieve FDA approval 3 months after the rejection.

However, as you can see from the document I have linked, the votes were a very decisive "no" in the case of Valstar's 11-no, 0-yes, when compared to MCNAs 18-no, 6 yes (with all oncologists voting yes in the case of MCNA).

When you consider the fact that Valstar was approved by the FDA three months after such a poor adcom vote, it does boost confidence that MCNA still has a good shot of being approved considering how much better its adcom vote was on a relative basis.

I also find interesting on page 21 of the linked FDA review document, you can see that even after the sponsor re-presented Valstar's clinical data post-adcom, the FDA reviewer still did not find support for approving Valstar. YET VALSTAR WAS STILL APPROVED BY THE FDA, 3 MONTHS POST-ADCOM, EVEN AFTER THIS DOUBLE REJECTION.

And finally, let's not forget the following, and most important:

MCNA's clinical trial data shows a favorable efficacy and safety profile when compared to the Valstar data that lead to its approval.

[Hatchchat]

BUT maybe it is "too safe" compared to valstar? lol... i really hope the FDA doesn't have such morons in its panel like there were in the adcom panel.

[ragingbull1234]

Ohhhh, but they do!    And the justice system has "dummy diddlers" like Kenny Kratz.  That's what I've been saying all along.   A lot of these educated people are corrupt and useless.   BUT.......   They are "yes men".  They will bend over, and allow the GOV to hoop them every single day of the year.   Haha.  "Teammates

[ragingbull1234]

If you want to see "Educated stupidity" in action, then I suggest you watch "Making a Murderer" on Netflix, and check out the Prosecution team.   In about 10 hours, you'll have an even deeper understanding of the kind of stupidity we are dealing with.    If I didn't know any better, I would think that these people actually believe they're good at

[ragingbull1234]

DO YOUR JOBS for eff sakes.   Legitimately

[andech]

@SteveMM according from what I have got from  my (possibly incomplete DD) the adcom voting was as follows: urology 4 yes, 1 no vote (which is very good and positive) oncology 8 no , 1 yes,if vote.(Which makes me wonder) you instead postesd: "(with all oncologists voting yes in the case of MCNA)." thnaks in advance for claryfication