TELESTA THERAPEUTICS INC T.TST

Early Approval?

[txbioinv]

Upon a positive vote by the ADcom for recommendation of FDA approval; I believe TST will receive an early 'unexpected green light' BEFORE the February 2016 PDUFA date. The Sanofi plant that makes the toxic BCG therapy is due to be back online by EOY supposedly, even if so, they have do their pilot runs and etc to resume fulltime regular production. I am not sure where Merck stands currently on production(they too had production issue). So my fellow longs, be ready, everyday, after November 18th, because one never knows what the FDA will do, especially if the TST Adcom travel team includes a couple dying patients waiting on BCG and a doctor or two giving statements of how their administering the BCG drug at 1/3 qtys because of shortages. Be ready and GL longs

[loveshackdave]

"especially if the TST Adcom travel team includes a couple dying patients waiting on BCG and a doctor or two giving statements of how their administering the BCG drug at 1/3 qtys because of shortages." Playing the BCG shortage angle would be advocating that MCNA be used as a first line therapy rather than for BCG refactory patients. I would think that the FDA would not look favorably

[ragingbull1327]

Why not keep pestering them about the fact that there aren't any other options??    If I had this disease and they told me that my arm would fall off because of the treatment, I WOULD STILL WANT IT.    The treatment might be baffling the FDA.   They are used to seeing bladder cancer treatments that don't work.    Maybe their minds are blown that a tiny

[ragingbull1327]

"Attention bladder cancer patients.   We know that the health industry has essentially done nothing for you for the past 25 years or so.    There is a new treatment on the horizon.   Its efficacy has been proven for more than a decade.   It's ALMOST available.   We have to take our time tho, bear with us.   We know you're waiting, but we have a

[txbioinv]

</br /lsd, after approval i can assure you tst will immediately start the process for first line use; until then doctors legally can use as a first line therapy and its up to the payers(insurance) to decide if they are going to pay. besides, that's why we hired the new gal.............a few more weeks to add and then the climb starts, especially when the float drys up(intentionally or not

[simouuun]

pls re-post. It is not readable.

[txbioinv]

ok. had to retype.....

[txbioinv]

dave, I can assure you TST will start the process after approval for first line use. Doctors can and will legally prescribe for use as first line therapy. The only question is will the insurance companies pay for off label use? ..................and that's why they hired this new gal............for her expertise in this area of payers. few more weeks to add. I have decided t keep 25% here for

[loveshackdave]

Right, right, but they can't pitch this to the FDA as a reason to give MCNA a pass. They also can't advertise it to doctor's or insurance companies as a first line alternative until it is approved for first line by FDA. Of course doctors will prescribe it and insurance companies will probably pay for it unless it is a lot more expensive than BCG.

[txbioinv]

Yes.....I agree completely

[DamnYankees]

LSD, none of this matters until the next round of options/dilution and reverse takes place. No volume and no interest in Telesta Or Banhelef until Options and Reverse. Come back in late February after the 15 for 1 at 27 cents US. These are the most compelling near term milestones as interest and trading indicates