TELESTA THERAPEUTICS INC T.TST

Valstar Clinical Trial: 98% of Patients Were White!!!

[SteveMcM]

https://www.bcan.org/wp-content/uploads/2012/10/Steinberg-presentation-final-10-25-12.pdf

Go to slide ten^

Which makes the hour that the adcom committee spent scrutinizing the racial composition of the MCNA clinical trial to be even more irrelevant. 

MCNA trial had the same composition as Valstar, which further supports MCNAs superiority

[ragingbull1327]

The scope of stupidity related to this approval process is unlike anything I've ever seen before in my life.  I'm not that old, but this is all pretty crazy.   Let's, for the sake of argument, say that MCNA efficacy was exactly the same as Valstar's.  MCNA is STILL a better alternative.   I've seen a lot of brilliant people do a lot of silly things, but the

[ragingbull1327]

Anyone new to this board will not have likely seen my previous posts and endless rants about how stupid this process was BEFORE yesterday's song and dance.   For nearly 3-4 years I'd say.  It began with the two spikes and drops from 0.40 to 0.90 or so and back down twice in a month or so way back when (2011 maybe?), for absolutely no reason at all.   That kind of trading

[ragingbull1327]

Also, some people have said that Telesta didn't present well.   I've watched the meeting 3 times now. They did an OUTSTANDING job.   This is not PFIZER or MERCK sitting at the meeting with the FDA.  This is a micro cap virgin.   And you think I EXPECT A LOT?    The FDA is the one that has the power.   How they don't see this immunotherapy as being

[ragingbull1327]

If there are people out there that honestly believe that this won't be approved, for whatever reason, then they should probably reassess what information it is that they find "important" when they are buying and selling stocks.  

[DamnYankees]

I think that any sensible observer would agree that the crux of the debate was forsaken early for on  a broad discussion on the merits of BCG, the already approved SOC that was not being threatened or unseeded in any way by the MCNA submission. I don't how a sober, right minded person would see it any other way. The FDA's publicly espoused guidelines for approval of what MCNA is

[txbioinv]

steve, Nice digging, going into my file saving for our FDA PANEL TORPEDO LETTER

[SteveMcM]

txb, within your letter you may want to also include the following: 1) An FDA panel in 2013 laid out a recommended clinical trial design. They couldn't come up with a concensus as to what should be used in the control arm (since the only thing available is Valstar and doctors hate prescribing it). Also, the agreed that a single-arm trial would be appropriate if certain long term cure rates

[txbioinv]

steve, yes, these facts will be in there in some form. saved to my letter fact file. I will be drafting rough draft this weekend and hoefully finalize by Tuesday. we have plenty of time. additionally, I am contacting BCAN and other groups; we must have there support regarding petition to get numbers and this effort must mainly represent patients, not investors. GL.... PS- no one be surprised if

[DamnYankees]

I don't think that the FDA is prepared to tell Bladder Cancer patients, survivors, their children, their spouses, some very influential Urlogists who attended Adcomm, and the Urology community as a whole  that they are pulling the ripcord on the most promising and approveable treatment it two decades over what did someone call it, a "Goat F$%#*ng".

[ragingbull1327]

I think so too, except there is one problem with our theory.    The FDA has taken an eternity to get us to this point, so people dying on their watch doesn't seem to bother them..... that might be the scariest part of all.   

[txbioinv]

Yes....lol....that was me, its to point now, I have to laugh, to avoid the anger. im taking a break, I will try my best to copy emails here. this stockhouse posting capabilitys is limited, kind of like mine, lol. GL....stay strong longs. ps- anyone who wishes to inbox me their email address, I will forward emails to them.

[diyodt]

txb...I am starting to get around to what you are trying to accomplish.  I think the focus should be twofold. First, contacting urologists is probably a worthwhile effort. Their opinion matters the most.  A concise letter as to what happened at the AdComm, includiing the posible ramifications for MCNA as a result, coupled with a synopsis of the data and trial limitations could sway

[DamnYankees]

I think it would be best to ask an experienced independant consultant before determining the course of action for any communication with the FDA. That was a devastating setback, and until we see how things play out, near term, who else's judgement in this crisis can really be trusted.