TELESTA THERAPEUTICS INC T.TST

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[SupermanLantern]

older but talks about exactly what you guys are mentioning here:

https://marketexclusive.com/high-risk-high-reward-on-telestas-panel-review/1004/

I am convinced it will be approved on narrow label with continuous testing required.

[noinstinct89]

Our BCG refractory/relapsing is already narrowed.. So how to narrow a narrowed Label?

[Hatchchat]

+1 MCNA will never suppress BCG, the US won't be self-defeating. If we narrow our already narrowed indication, the MKAP of 180 million dollars is all we will ever get. Means shareprice of 0.60.

[JPMUSSE]

MCNA's PDUFA (Prescription Drug User Fee Act) date is in late February 2016. We believe the FDA could disagree with its advisory panel and approve MCNA as an early-stage bladder cancer therapy in patients who no longer responding to BCG but would prefer to delay removal of the bladder, if possible. The drug exhibited a one-year disease-free survival rate of 25% in an open-label, 129-patient

[Mackinnon80]

Could you please explain us you you get to that number of 180 millions ? Probably with a complex mixtes of dice rolling and meditation... Unfortunately, It seems you don't understand at all the role MCNA intend to play for the NMIBC patients. The goal here is not to replace BCG. Certainly not short-term or mid-term. But just to help patients who failed the BCG therapy or who cannot tolerate

[Xiawen13]

I think the 180 milion comes from a recent comment from an analys (was it Euro) saying the peak estimated United State revenu for MCNA would be 188 milions in 2025. But I think this same analyst continued after saying there would also be around 254 milions revenue outside USA. I have a question for you M80:  wasnt the primary endpoint set by the FDAat  40% to 60% disease free . DIdnt

[Xiawen13]

There it is M80 : Our model projects peak U.S. MCNA sales by 2025 of US$188M, obviously predicated on FDA approval, and global MCNA-derived revenue that year, including rest-of-world royalty revenue from Ipsen of US$254M. --- https://www.thelifesciencesreport.com/pub/na/16869?utm_source=delivra&utm_medium=email&utm_campaign=TLSR+Final+1%2D13%2D16 Please check my question to you about

[Mackinnon80]

I'm aware of the number from Doug Loe' latest analysis. But that 188M U$ (or 254M U$) is an annual revenue...and our friend Hatchat is talking of a market cap of 180 millions. For a pharma with a high margin % product (like MCNA), the market cap is usually at least 10 the revenue. Exactly why the number he mentionned (market cap of 180M Can$ or a SP of 60 cents) is completely off-track

[SteveMcM]

Mackinnon, the $254M is peak sales, not expected until a  few years after launch.  The share price listed is a one-year target, reflective the lower sales estimate in earlier years.

[Hatchchat]

now tell us mackinonn80 where do you see the most probable mkap after the most probable way of approval for you?

[Mackinnon80]

Just to put TST ' value in context, when a small biotech is taken over by a giant pharma just before or right after the FDA approval, it is usually for a price over 3, 4 or 5 times the peak sales revenue (by the way it won't take 10 years for MCNA to reach peak sales...I strongly disagree with Doug Loe estimate on this). I'm not suggesting this is how TST is going to be valued in the

[Mackinnon80]

You have to understand the signification of a "narrow indication". Every oncologic drug on the market have a limited label. Meaning they are limited to a specific (or limited) population. If the FDA approves a label that includes 60 % of the initial targeted population by the sponsor, will you call it a double-narrowed of a narrower indication ? My point is...the word "narrowed

[thathurt]

sl, IMO this entire chit chat that everyone brings up re. "narrow label" is borne and lives in silliness...as best i know (read Adcom transcript and BCAN and???)  surgery aka cystecotmy (or aka the blue light special) is the real general 1st line treatment and i believe it is as it has the best outcomes...so BCG is 2nd line (specialty front line for surgery unable, etc.) and key is

[thathurt]

ps, i forgot to add the financial modelling of this "surgery unwillin or unable" is beyond the run of the mill bio analysts in Canada (que up the last whomever it was) because they simply have limited to no data and how big a surgery unwilling or unable group is as imo there is no public data about them...BCG sales and volumes are estimable but unwilling and unable is pure speculative

[thathurt]

pps re. CEO or COO getting canned over AdCom fiasco, IMO the old BNC suffered badly and nearly collapsed due to lack of accountabiliyt of the CEO by the BoD...the AdCom failure was very strategic and completely unacceptable to me, proper accountability holds the CEO to account..it is IMO easy to raise money at deep discounts it was IMO obviously beyond the TST leadership team to design and deliver

[blartar]

pps re. CEO or COO getting canned over AdCom fiasco, Nobody gets canned @ TELESTA , they just get MORE OPTIONS !!!!!!

[ragingbull1234]

Why would the EXECUTIVES of TELESTA get canned?   The FDA's AdCom should be cancelled across the board, because it's a corrupt and stupid idea to begin with.    I'd fire the entire Food and Drug Administration and start with a new gameplan.   WORK FASTER AND MORE ACCURATELY THAN THE LAST PEOPLE, OR WE WILL REPLACE YOU TOO, WITH EITHER PEOPLE OR COMPUTERS THAT CAN

[ragingbull1234]

33-34 cents Canadian.   Impressive once again for these people.   Shave 15 cents off from here and I'm back to ground zero and get to buy more without making OPM average cost rise!!  Double-dare!   ;p   Our 0.198 across the entire lot is looking pretty good right now I think!!!    They're scared to go to my price because they know they won't get the

[ragingbull1234]

Yep.  I was right.  Again.   I'll make the same bet again tomorrow.  In case you haven't noticed, and judging by some of the posts on here, you haven't, they're incredibly good at proving my arguments for me.   Every.  Single.  Day.   I'm not so sure Id even believe the news that they've come to a decision, even when they do.   &

[ragingbull1234]

I guess I'm just happy that I'm not old enough to actually believe that they need this much time.   To do ANYTHING.   if you cannot keep up, then please get out of the way

[ragingbull1234]

Ive come up with a new, more fitting motto.   "We The FDA.   Stymying advancements in human health....Since inception.    Sure, we aren't the best scientists.   Those people work for the drug companies.   We aren't the best doctors.   Those people work for themselves.    We have found what we are good at though - exceptional even - and

[ragingbull1234]

Keep THIS is mind too.   If anyone. ANYONE!  can own Blackberry stock in 2016, then the human mind is capable of anything.    There is no good reason to even list that stock anymore, and $5 billion of the most optimistic money I've ever seen, sits dead in that stock.   Bahahahahaha.    Jokers.  The lot of you.   Pffffft.  Blackberry.