TELESTA THERAPEUTICS INC T.TST

Adcom voting results

[thathurt]

..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

[IWillRetireSoon]

THANKS. This is very interesting since the main concern and looks like the only concern was with the trial size. This is something that everyone is aware of including the FDA. So really the panelists are just covering their arses and being really cautious. Did the FDA already state to Telesta that the small trial size was OK? NowRetired.

[DamnYankees]

Good Synopsis. The blatant black eye on this Adcomm was that 90% or more of the discussion was not anchored to the FDA/AUA trial standards. I heard more concern forbthenlacknof minoritiesbin the trial than I did regarding the revised trial standards and how MCNA performed relative to them! On the few occasions the conversation could have headed that way it drifted off into irrelevance again

[ragingbull1327]

Great read.  Thnx.   

[txbioinv]

hurt, much appreciated for your digging, this will help bigtime. I have no time for watching and/or reading the 8 hour goat f*ck. however, rest assured, my letter will be thorough, not overwhelming, and tactful; I can type one helluva memo. thanks, txbioinv

[thathurt]

as you evaluate the "no" votes you should be struck by two issues: a) no not proved (bad study design) b) better indication would be supportable and in general c) good safety profile.. ...this suggests to me a number of confusions during the AdCom meeting: a) bad trial design shouldn't support any real positive conclusion on demonstrated safety but b) not proved...this has

[ragingbull1327]

Good assessment.   Thx again

[DamnYankees]

Good insight. Are you intending to represent Telesta in their next round of discussion with the FDA? Obviouly TST could not be expected to deal with the myriad of inconsequential topics that ate up large amounts of allotted time but who exactly was or should have been responsible for reigning in the discussion to focus on MCNA as it relates to AUA/FDA guidelines for approval. Was that Telesta'