TELESTA THERAPEUTICS INC T.TST

The Voting Question

[greenbacks]

Voting Question: Does MCNA have an overall favorable benefit-risk profile for the treatment of non-muscle invasive bladder cancer at high risk of recurrence or progression in adult patients who failed prior BCG immunotherapy, e.g., in patients who are BCG-refractory or BCG-relapsing?

There are a number of questions for them to consider in the document... ultimately the question above is what they are voting on.

https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/BloodVaccinesandOtherBiologics/CellularTissueandGeneTherapiesAdvisoryCommittee/UCM472804.pdf

[BeenHereBe4ore]

This post has been removed in accordance with Community Policy

[ragingbull1327]

If they don't approve it, they're the dumbest and most ignorant organization that has ever walked the earth.    Give me 2 reasons why it won't be approved, and I'll accuse you of grasping at straws to come up with an argument...

[barneyj44]

Two reasons we won't get approved, 1. Were a Canadian Company 2.Were a Canadian Company from Quebec, hope I'm wrong as I'm a bagholder going on 12 years.....

[rgonlyfactspls]

BarneyJ...don't spend another second thinking about that. Dr. Berendt (and Team) have pretty much thought of every concern possible and worked through them with best answers /solutions possible (shows in spades in MCNA's Adcom briefing document). Now this respect to your concern...and it's just a rumour...but I hear Dr. Berendt has a Santa's bag filled with item in article/link

[barneyj44]

Thanks Rg it's been a long road for us.

[rgonlyfactspls]

That's an understatement. But. it's also been a long time since I have felt this confident of how the future will unfold for Telesta and our investment. Broken promises (of the former management) have now been replaced with results. Two years ago I would never have believed it possible to potentially have MCNA in the U.S. market in early 2016. Saving lives and families a horrific

[terr2]

With the history I have witnessed here, over the years (since Jan.07) you all better have your stop losses in place. Not trying to be negative, just sayin. Their determination to do this 15 for 1 RS is very disturbing. Our SP has been kept in check in order to follow through with it. Makes no scene. JMO

[wasagastar]

The wording says up to 15 to 1 and if and when. A Nasdaq listing would be terrific and likely something they want in the new year. But I will say if tomorrow's event is priced in - it doesn't look like it will be a successful day....

[ragingbull1327]

Are you SERIOUS?   You would put a STOP LOSS on this stock to protect against downside from this SP?     That's the difference between you and me.   I'm not putting a stop loss on it until it hits $2, and I'll move it up once the ignorant dummies start buying.    Not selling.

[ragingbull1327]

I'm pretty sure that they want you to do exactly that.   Set your stop loss and then grab your shares on the cheap.  

[ragingbull1327]

This game would have been much easier to play had you played their game before they did.    Knowing what big money will do before they do it is how you will make money in this game.  Old management didn't LIE to people.  They just moved slow as eff just like everyone else and promised the world.    Actually, just a couple of years ago Santa stated in the

[ragingbull1327]

I'm pretty sure that Santa will have a class-action lawsuit against his entire net worth if it doesn't go to market.   What a stupid thing to state as fact in a publicly distributed newspaper.    It's actually the ONLY reason I bought the stock.   His words are binding, but I never knew he was the jury for the FDA.   

[13PunterDog]

Bingo!! How true RB. Only thing that matters is we are better than Valstar, the only FDA approved drug in comparison, end of story. All the end point  and single arm talk  is moot, pure subterfuge. In laymans terms, the good has to outweigh the bad for this drug and you will see that layed out tomorrow , no problem. Don't give your shares to the big guys so they can all laugh their

[ragingbull1327]

I won't sell to anyone anytime soon. :) Good luck longs.   So long shorts

[tater1]

Not so sure it's that simple.  If this is how the FDA reviewer's discuss a BLA they like,  I would hate to be part of a submission they didn't like. 

[txbioinv]

Damn right, not selling one damn share. For many here this will be a life changing event, for some no sack no glory. I will be patient and sell when my total gross value is near 7 figures or higher, yes, that's freakin six zeros. The good Dr has pulled all the right switches and obviously him and the COO and ole little Monique know how to converse with the FDA...........the promise land is