TELESTA THERAPEUTICS INC T.TST

some more interesting commentary from Adcom:

[thathurt]

...and FYI i was actually very surprised at the vote result

so here is Bartlett (i believe)  speaking to Q 4 proposed indication:
"extremely similar to BCG and in some ways better than BCG, then MOA is likely like BCG so is it better than BCG.."
comments on Q5 were similarly marginally positive

... and then boom on the vote he was a no vote and then going again way off board he states it could be a useful alt to BCG...BCG is 1st line, MCNA is 2nd line MCNA is not an alternative to BCG and Bartlett i had down as a bladder cancer guy...his comments were simply baffling

... and i suspect this bafflement is what both TST and the FDA see

[DamnYankees]

Hurt, you are a smart fellow. Can you tell me the last drug that was rejected by Adcomm where the active practioners in the field of expertise (in this case Urologists) and application  for said drug were outvoted by the balance of the panel? Funny that is. Hunch says it is a very short list.

[DamnYankees]

Further to my last point, and as Telesta is allowed to trade down to cash value, what precedent has the FDA used for a ruling contrary to Adcomm. Have they ever seen a situation like this Gongshow where the majority of  Active/practising Urologists (those who actually treat Bladder Cancer daily) supported approval, other Urologists indicated they could support approval and the remaining

[thathurt]

damn, IMO the final vote was to a specific question #6, there were 5 other questions, 3 or 4 of which IMO has postive responses... ..but key is it was too a very specific question, again IMO the solution is add 8 words to the question/indication/label and everyone smells like a rose..Committee advised, FDA took advise and changed label, TST says great (as in effect it changes nothing)..if however

[DamnYankees]

I am not a Urologist or a Telesta executive but 100% concur. If "Surgery Unfit or Surgery Unwilling" were added it was a Yes vote and a healthy majority. Wasn't that brought up multiple times? Yet Some were so far off the mark that even this addition may have eluded them. Of course, while providing approval,  this indication would limit the rev protential, near term at least

[ragingbull1327]

I bet if someone put up a lot of 20 million shares all at 30 cents, they'd be gone in a heartbeat.    It doesn't go up because there is no reason for it to go up.   Not enough shares to steal for the cost.  Simple math. 

[ragingbull1327]

If people were selling, you would get your spikes.   Since the only thing people are doing is holding (as indicated by the poor volume on such a news release would indicate), there's nothing to do but just hover and wait for the next catalyst to scare the chit out of whoever is left.    The people that remain after that are the ones on the boat when she sails.   Iceberg?

[thathurt]

damn, it will have zero revenue impact and that is part of the beauty... surgery in bladder cancer is if i remember correctly recommended 1st, 2nd, 3rd, 4th, etc. before any other treatment regime even BCG..so you reject surgery and get BCG, it doesn't work you reject surgery again and get BCG again, it doesn't work you reject surgery again and get MCNA.. ..the unfit will always get BCG

[ragingbull1327]

Would it be a different group of people at the FDA who would determine that the amount of caffeine and other stimulants in a Monster Energy beverage is a safe amount to be drinking in moderate amounts (2 cans per day) every single day?     Cuz that's legal.   I wonder how much money was spent on their studies.    Maybe we should have made MCNA an over the counter

[ragingbull1327]

The hippocracy between what is and what isn't available to the public is enough to blow the hair right off your head.    Is there a definitive negative correlation between higher education and common sense?

[ragingbull1327]

I guess if they have more cancer triggers, they'll make heftier profits on the treatments.    That's actually a sinister thought.   What if Philip Morris or Altria own Healthcare too?   lol.  Sinister win-win