Adcom voting results
..someone asked for it and IMO it is a useful point for discussion and understanding...
... a big caveat, what i post is not intended as an attack on any member and i could be wrong but this the vote i recorded (they had the vote results posted up on a screen) and names may be spelled wrong (that papa one in particular) and my summation of their comments may not be exectly correct but essentially correct:
1. burstein no not proved
2. rini no not proved
3. novakowski no not proved
4. manefree no somewhat conflicted it is safe and does benefit some patients; but study not well designed
5. diehl no alt tale of two drugs; couldn't get a cystectomy does help for others; would approve with a better indication
6. roth no study design was not good enough; didn't prove benefit
7. cole no didn't prove emens no alt likely has a role but difficult to approve given lack of data 8. pavlovich no study design not proving
9. zowein no true benefits not proven
10. bollard no study limitations
11. icason no not clear
12. mitass
13. pluhar no not a positive risk benefit ratio; safe but insufficient data on benefit
14. rose no alt very reluctantly voted no; but given a change in the question I would
15. lancett no really conflicted; trial problems
16. bartlet no could be useful as alt to BCG;
17. fojo no alt trial was too small; we all wanted to vote yes, we think there is something here and please FDA do something
18. papad no like to say yes but study too small; drug is safe and no harm but approve not on no harm; very disappointed that no approval for decades
19. walsh yes safe for sure but should be available
20. hanno yes thoughts benefits greater than risks; didn't see a downside and didn't think there was a downside
21. agarwal yes alt need more options and this is one; difficult trial environment
22. cripe yes safe and some benefit
23. griffith yes deficiencies raised and weaknesses outweighed by strengths; safety was vey important
24. touzell yes really believe patients entitled to a chance; trial was flawed in its infancy
of the "no's" where they specifically answered affirmative to an "alternate indication" (which i believe was surgery unfit or unwilling) i id'ed it and beyond that some did indicate a willingness to a different indication even if they didn't answer yes to the specific alt...
..so the above is what it is and IMO the strategic messaging error was this, notice the "no's' never referenced the AUA/FDA trial standard nor the Valstar trial and IMO that was the strategic error..it seems to me without those significant points of reference ingrained in the discussion the trial (as it failed to meet prespecified endpoint) on face value is easily considered a failure...it was not a failure IMO when measured against the AUA/FDA standard...and worse if i remember correctly it was brought up more as a question/discussion there was confusion FDA clarified in about 30 sec after lunch and off they went..if TST hadda had a "coach", that coach would've seized on this and moved the discussion more to where TST/FDA were/are on the subject..
ps fojo was funny he kicked TST throughout the day and then says yes to alt (likely knowing it was straw dog) and then pleads for the FDA to do something (this was stunningly surprising to me)
..so i agree with Doug Loe regulatory risk just increased 10 fold but i believe an adjusted label (which IMO is irrelevant anyways as surgery seems the preferred choice before all else and the label will just specify what is practice anyways) will get a go from the FDA
..all above IMO; hope this helps fill some gaps for some people