TELESTA THERAPEUTICS INC T.TST

Label

[Xiawen13]

It seems the most likely label would be "cis containing, bcg refractory, unwilimg or unable to undergo cystecomy."

but the adcom seemed not to adress question 3a, therefore i didnt find trough the transcript a clear comment in favor of that label.  In their final decision adcom member only commented on the "unwiling or unable". M80 my question is WHY

also, a new chemotherapy "myocyclin" treatment just came out and have better effect on papilary cancer than BCG, so i think it supports my view on the CiS label

again m80, any comment?

[Mackinnon80]

Xiamen, Myocyclin is an antiobiotic. It is use/used to treat infections. In fact, according to new studies, bladder cancer could be a side effect of taking myocyclin. From what I read, it's of no use to treat NMIBC patients. Please give us a link if you have something on this. Back to your question. True that question 3a was quickly discussed (page 200 of the transcript). Only Dr Agarwal

[HighteawithIntrepid]

Many Thanks. With our modern technology my view is to go to a 0 to 10 voting system. Surely to God we have moved beyond  yes or no and a third button that rarely sees the light of day.

[Xiawen13]

Thanks m80, here is the link for the chemo more effective than bcg. It seems to apply only to papilary, so i dont think this drug can replace bcg and mcna for the cis  https://www.renalandurologynews.com/bladder-cancer/chemohyperthermia-safe-effective-for-nmibc-adjuvant-treatment/article/467329/

[Mackinnon80]

That link referred to mitomycin C...not the same thing that what you wrote in your first post (minoclycin....an antiobiotic) ! Mitomycin C was the comparator in what was supposed to be the second phase 3 for MCNA. The recurrence-free survival (RFS) numbers cited are not that much impressive for papillary-only tumors. The difference with the BCG group (the comparator) was non-significant. Also

[Hatchchat]

M80, what's your guess on mcap for your most probable narrowed indication (CIS-contaning disease patients who failed BCG that can't or won't undergo cystectomy)?

[Mackinnon80]

Like many TST shareholders, I think our upside potential is limited on the TSX. The Toronto stock exchange is one of the worst place to be traded for a biotech that hopes to be fairly valued. PLI is the best example. In the first week of march, if the approval is for the CIS-containing disease population, I see a market cap anywhere between 300 to 600 millions Can. Quite frankly I would be

[txbioinv]

m80, if you invest in biotech/pharma on a regular basis, all that's been in the news from the recent immunotherapy/oncology drug developments/approvals is EARLY APPROVAL, ON AVERAGE ONE MONTH; additionally recent interviews with FDA bosses have confirmed those actions/intentions.......................................maybe I am correct about our decision......just one day late. At worst, I hope

[Mackinnon80]

You might be right Txbioinv. All I know is no management would announced they have received a CRL letter at the start of the day like this. To be halted like that more than 3 weeks before the PDUFA date, I believe there is more chance to get good news than bad news. We'll see. M80

[txbioinv]

M80, your correct, usually CRL news end of day, I've seen a few in the AM but it doesn't matter because it must be dealt with, good or bad. There's a damn drug shortage big time and MCNA is safe; if this is disapproved for any reason, time to raise hell, ........................my plan is waiting. GL longtimers

[cndexpatman]

Well it's not approved so too bad for you and all of us that placed faith in a crappy management team that made AdComm seem like amateur hour. Really too bad.

[Hatchchat]

do you now it's criminal to spread such "statements" as the truth if it's not true. can you prove it?

[txbioinv]

And who are you talking to? be specific hatchit.

[redatnight]

Hey cndex...you are one real buzz kill!

[txbioinv]

I agree 100% on that. ..............

[Hatchchat]

i'm talking to the guy claiming that the FDA did not approve it. if he can not prove this statement and does spread false information on purpose, it's a crime and illegal.

[txbioinv]

hatch,..........yes, possible factual slander against company. That poster has been a two faced poster here all along, soft bashing along the way. There are people here with devious agendas,,,,,,,,sad but true. GL