TELESTA THERAPEUTICS INC T.TST

"Black Box WARNING"...

[somweyungguy]

How might that go...

This drug is non-chemo, has an excellent safety profile, is extremely well tolerated, while offering an efficacy at least twice that of the current drug being used for those unable to have or unwilling to have their bladder removed.

Furthermore, the company manufacturing and selling the existing  inferior option is already our partner and is a major US player.

I would partner with ENDO for the US and let them talk to the FDA....just say'n

GLTA
Sqr

[loveshackdave]

I would think that the black box warning would be something like: "Delaying Cystectomy may lead to an increased chance of mortality." Also, from what I've read, the efficacy is comparable to Valstar not twice as effective. The FDA's adjusted complete response rate for MCNA is 20% and Valstar is somewhere around 18%.

[Mackinnon80]

You don't have the right number LoveSD...here are DFS at 6 months, 1 year and 2 years respectively, for CIS containing disease & BCG refractory : MCNA     : 27 % / 18 % / 10 %  (from FDA own briefing document) Valrubicin : 18 % / 10 % / 4 % So yes MCNA appears slightly superior to Valrubicin. Don't think because a bunch of statisticians and non-orologists

[loveshackdave]

the 27% was from Telesta's own analysis. The FDA's analysis of the data had the number at 20.9%

[Mackinnon80]

In your first post, you compared Valrubicin 6 months DFS (18 %) to MCNA 1 year DFS (20.9 %). That's why I said you need to use the correct numbers to have a fair comparison. MCNA' 6 months DFS is 27 % and accepted by the FDA in their own briefing document. See page 42. I suggest you read that document again. M80

[Biostocks01]

Excellent post!! According to you, as a percentage, what are the chances of approval of MCNA? Thank you in advance!! Bio

[vega509]

why? because Endo did so much for TST(Bioniche) previously.

[18tee20]

Eactly, TST damwell better not partner with Endo again!  Wouldn't Endo just love to be able to mothball MCNA one more time.  Why would Endo want to pay a significant sum for 50% of the profits from MCNA when they already have 100% of the profits from Valstar?  The longer they can delay the approval of MCNA the better for them.  It would not surprise me if the urologist that

[thathurt]

18tee, this endo stuf is just more BB idiocy, that has gone on here for years....but re. an Endo backed AdCom participant who knows not me for sure...but i will tell you this i had expected a split but positive Adcom decsion by profiling the participants...i would expect and demand that TST execs knew in detail with expected 90% confidence of base line how each member would vote (i did my research

[DamnYankees]

Hurt, I guess questions like pricing and racial makeup didn't enter into the mock throughs that apparently preceded Adcomm. Telesta management and their consultants must have been awfully confident in what they saw in the pre game video  to send Monique to center on her own. Awfully confident! That's right out of the Belichek playbook and they nailed it didn't they. Hopefully

[thathurt]

damn, as far as i know drug pricing is a post approval item, potential pricing is kept confidential by any and a competent companies...i believe del fugo (or whatever his name was) knew this but went fishing...and found a fish as the VP's response was pure country bumpkinism (ie she didn't know and failed to give an appropriate response which should've been "none of your GD

[DamnYankees]

Although she seems too courteous a person for that the train was off the tracks by that point anyhow. Nice to see a trading day unmolested by manipulators. Enjoy the weekend.

[thathurt]

damn, no she never would but i suspect the COO could've and would've. the asker of the question  (del fugo or whatever)i had profiled as a shitee disturber and a no voter before the meeting...he loves chemo and only chemo cause it is cheap and old people aren't worth saving...

[thathurt]

more idiocy from someyoungidiot, only this time with a sufficiently harmful header that i will respond, there is 0% chance that MCNA if it is approved in any way shape or form will ever have a black box warning and anyone posting this idiocy should be viewed as an attempt at price manipulation... a black box warning is related to a dire warning about the potential of a drug to actually kill or