TELESTA THERAPEUTICS INC T.TST

how good was TST's preparation and AdCom Strategy???

[thathurt]

..so concensus seems to be that AdCom execution failed miserably, just check the vote, but i gotta wonder was the failed execution built on failed preparation and strategy...

..i wonder this for many reasons but based on this one alone primarily, i forecast the vote would have been 16 yes and 6 No (i didn't expect the full 25 panel to vote) and i broke it down as such: i had 7 bladder cancer folks who i thought would all vote yes, i had stats and chemo (fojo???) voting no and then i had 9 "soft" yes votes (like folks in brain cancer, etc. but somewhat unsure given their affliations with MD Anderson, etc.)

..we had also read that in fact TST did "faux" AdCom's with various experts but i wonder if their practice sessions really focused on the likely negative commentary that may occur (which is a broad measure but basically is all the non-301 related stuff) and i ask this as they seemed unable to communicate well on some difficult items and i will use one example in particular:
- one member who i've posted on before stated that he believed only 3 responses in 93 patients could be directly attributable to MCNA...that was a stunning statement (it was backed up with appropriate commentary IMO) for which TST had no really good response and IMO was a signficant contributor to the no vote..

maybe it seems that TST hadn't prepared well enough for a difficult session and if i could easily estimate resistance TST should have banked on it and prepared for it.

[bigswein]

Telesata ran mock ad-coms before the "real deal". Some say they were slaughtered, or were they? While it is conceivable that "mon cheri" has cucumbers and lollipops on her mind one would hope that she climbed the corporate ladder for other reasons. And although "Weee do not ave zet infoRRRmation" was repeated more times than one would like to hear there are other

[ragingbull1327]

if the treatment is for NMIBC, can I ask now why there was anyone in the room on the FDA side of things BESIDES Urologists?    Why?

[thathurt]

bigs, i have a different opinion, "slaughtered" is pretty inflamatory but 18 no vs. 6 yes is a substantial and very negative outcome..and i save harmless the entire team that was there to present including the VP.. ..IMO and based on listening to the webcast and the commentary was this: it was a small single arm PIII trial that failed to meet its primary endpoint objective...that is a

[arghh]

Was it Telesta that wrote the question when they really should have focused on item (b), and by doing so got in over their heads, especially by not having more senior personnel there as back up?

[thathurt]

arghh, yes sort of maybe but likely, IMO the VP was out of her "pay grade" when not just factualizing which b) is about....it is more interpretative and more sophisticated and flexible way of looking at patients compared to what was formally presented at 301 inclusion/exclusion criteria, etc...and as best i remember it was not part of the core presentation (which likely would not have

[givmeabrake]

Bottom line...others control the narrative. Telesta must step up and push back. They need a communications consultant ASAP. Good news is...They can afford it... Bad news is they don't value the power of communication. This article's title clearly reflects the sentiment of decenters on the 18th Telesta Bladder Cancer Drug Delays Cystectomy, But Does It Slow Progression? By Sue Sutter

[thathurt]

brake, yes they did lose control of the narrative...re. communications consultant i doubt it would help as the FDA wants science not word smith... ..interestingly what you posted is one area where i thought TST had at least some response (if you listened to the webcast it was that one line graph going from top left to bottom right and where a statspack request and got (after lunch) some idiotic

[KingSarloc]

Enough of his over analyst! I said buy your shares and load up because TST is going up again ! Word from montreal this is trending up and buy now and get your cash back! heed my warning this at least last time I said to cash ur profits and I'm not sure if anyone did but I did and I'm loading up already so keep it up!

[givmeabrake]

They didn't lose control , they never had control. Don't you see the pattern? There is a campaign in play against MCNA ever seeing the light of day. Case in point ,how was a smart neurosurgeon like Ben Carson ever convinced that dinosaurs actually roamed the earth 6000 years ago? Indisputably scientifically false. My point being; just becasuse FDA are a group of smart folks with good

[DamnYankees]

GMB, what if they already have an answer from the FDA and Adcomm, good, bad or total Sh$;show, was just a formality,  but a politically necessary gormality, considering the "out of left field" nature of MCNA itself relative to the current SOC? Who's worried in Montreal? I don't think that anyone is.

[thathurt]

damn, AdCom is implemented at the sole discretion of the FDA, if they had decided to approve MCNA they would not have had an AdCom..if they were still awating to do some things like mfging audit they coulda done that then decided on AdCom...

[DamnYankees]

I agree that it was at the discretion of the FDA. I am not disputing that. Yet, sometimes when you are attempting to introduce a product into a stagnant, innovation deprived, dyed in the wool market space the implication or impression of offering insight and feedback to the decision makers in that market space is helpful. I am thinking from my own experience in technology but prior to entering, It

[thathurt]

brake, i don't see it, MCNA is not as best i know trampling on any significant in-place 2nd line treatment, as i posted before MCNA faced criticism from the chemo crowd but they off-label which i suspect the FDA doesn't prefer...so who is the group..ps TST had a powerhouse ODonnell, i doubt they could find a more qualified person but who knows