TELESTA THERAPEUTICS INC T.TST

Sanofi delays BCG production to mid 2016...

[Mackinnon80]

See this news release last week :

https://www.ashp.org/menu/DrugShortages/CurrentShortages/Bulletin.aspx?id=915

Sanofi was suppose to be back into BCG production early next year...meaning in the coming weeks. They won't before mid-2016, leaving Merck again as the only BCG producer in North America.

The BCG shortage situation will without a doubt plays a role in the FDA' decision next February. Even with a 0 % chance of BCG shortage, the benefit-risk ratio is still favorable for at least the "high risks CIS-containing diseases patients" label.
But giving that BCG production has been an ongoing problem for more than 4 or 5 years, I don't see how the FDA could reject a drug like MCNA (which  appears like a safer version of BCG) knowing how fragile is (and always will be) the BCG production.

Off-label revenue could turned out to be huge for TST. In the US but also in Europe where the BCG shortage has been severe too. Smart money knows it. This could be well over 2$ can in 2 months.

M80

[13PunterDog]

There is something seriously wrong with production of BCG with both manufacturers. Having production problems with two separate manufacturers at the same time approx? REALLY? Something wrong with the strain they have to use? Mutating somehow? Probably the reason we got to submit BLA for free on a small trial and are being pushed along by FDA. MCNA is virtually the same as BCG without the toxicity

[Mackinnon80]

You're most probably right 13PD. And when we look back in 2014, the timing of events seems to confirm that the FDA had a lot to do in Telesta's decision to file for marketing approval of MCNA in july last year. The last (North American) BCG shortage was made public on August 25th of 2014. The FDA was certainly aware, way before august, that another shortage was coming. As they often

[cardu]

"And when we look back in 2014, the timing of events seems to confirm that the FDA had a lot to do in Telesta's decision to file for marketing approval of MCNA in july last year." A while ago I posted a similar sentiment. I felt, at that time, that the FDA had already decided to approve , but had to go through the established processes. I am still of the same opinion.

[DamnYankees]

Mac. Listening to Adcomm and reading the transcripts there was little discussion of the BcG shortage. Maybe it was not a defined discussion topic but with all the unrelated rambling it seems unusual that it was not discussed. Obviously the FDA is well aware but, other than this board, I have never heard or read an opinion that thought it would have an impact on the BLA decision. It seems logical

[Mackinnon80]

DY, Officially a drug has to be able to stand on his own feet for the indication proposed by the sponsor. In my opinion the FDA can't publiquely imply that the MCNA would be a great backup to BCG in case of shortage. I would assume they can't and won't promote off-label use. True that analysis like seeking alpha and others haven't really based their opinion on the potential help

[DamnYankees]

Good Summary Mac. There are 3 opposing/related considerations. Firstly, MCNA has to sink or swim in its own for reasons of precedent. Secondly is the BCG shortage which looms heavily over the decision for any pragmatic FDA official, but can't be discussed in relative terms. And thirdly, and also important, the 2 main manufacturers of BCG are extreme heavyweights.The  FDA has to tread

[arghh]

I note that Feb. 27 is the "review goal date". I wonder if this latest setback will accelerate that a bit.

[thathurt]

arghh, i suspect the FDA has been completely on top of the entire BCG issue and any news to us is not news to them, i suspect they operate on the shortage until proven not principle..i suspect as BCG is a low margin drug it gets very limited funding from suppliers, it needs valeant to buy it and up the price 1000% then the shortage would disappear

[ragingbull1327]

It makes sense to me that the FDA was privy to information ahead of time.   It's been proven that it takes these people an incredible amount of TIME to discern information.   My mind is blown by the trading today.   Do my eyes deceive me, or have we actually pushed 1,800 shares across the table today at 0.39?    Wow.   This is how we roll...... no wonder no one

[thathurt]

M80, i wonder if pharmaguy (????) can chime in, he is the poster who consults to pharma and has experience in FDA approvals, but as i understand the FDA has a formal 550 point evaluation process, most of which is internal to the proponent (clinical data, CMC, etc.)...but i believe Adcom is considered as are cancer advocates/patients and i believe state of access to care is also considered (ie BCG

[Biostocks01]

Great post M80!! Regards! Bio