TELESTA THERAPEUTICS INC T.TST

Thanks Doug.

[rgonlyfactspls]

Note: this is a U.S. publication (just released minutes ago)... "A Bucket of Canadian Stocks Set to Soar in 2016: Euro Pacific Canada's Doug Loe" TST excerpt.... Taking each in turn, Telesta was a new coverage stock for us last year. Our initiation report was published in March, just weeks before the firm filed its biologics license application (BLA) in June for its mycobacteria-derived nucleic acid-cell wall complex biologic (MCNA) as a therapy for BCG-refractory non-muscle-invasive bladder cancer (NMIBC). This niche cancer market is somewhat unique in that it is an interesting hybrid of characteristics describing advanced disease (it is already refractory to first-line therapy) and early-stage disease (it is still localized to its organ of origin). The drug itself has an interesting clinical/regulatory history, mostly because existing Phase 3 MCNA data was generated long ago, and was deemed by Telesta and former partner Endo International Plc (ENDP:NASDAQ) to be insufficient to support FDA approval. Well, time rolls on, and the BLA was subsequently reviewed by an FDA advisory panel in November, which chose not to recommend approval even though the FDA actively encouraged Telesta to file available data, and even though MCNA was tested exactly as FDA recommended that BCG-refractory NMIBC therapies be tested, and while essentially meeting efficacy endpoints the FDA publicly stated would be medically relevant. 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 Phase 3 study. If you believe a trial with these descriptive elements is insufficient for approval, you are not alone; 18 advisory panel members agree with you! However, the FDA and the American Urological Association disagreed in a mutually endorsed set of clinical protocol guidelines published in 2014 in the journal Urology, and this stands as our best evidence that key regulatory leaders believe MCNA performed sufficiently well to be medically useful in BCG-refractory disease. We will know in seven weeks if the FDA will sustain its views and approve MCNA. The drug is partnered with French specialty pharmaceutical giant Ipsen (IPN:EPA) for rest-of-world markets, and this partnership provides separate endorsement for MCNA's regulatory prospects. 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

[simouuun]

Thanks RG. Would be interesting to know , how he calculates these mcna peak sales?

[noinstinct89]

So why he has a "hold" with 0,30$ on TST? https://www.cantechletter.com/2015/11/telesta-therapeutics-gets-price-target-slashed-at-euro-pacific/

[rgonlyfactspls]

noinstict89..."has" is now "had". See posts of late yesterday aft.

[noinstinct89]

ah, thanks RG. is there a new price target too?

[rgonlyfactspls]

Didn't see a price target in this aft's article. And, on the consensus forecast (by 4 analysts) SL posted yesterday, only 3 of the four analyst's provided an actual price target. Not sure if Doug Loe did or didn't. All four provided a rating though per bar chart info. Quick review will give you the price targets of the 3 providing --- https://markets.ft.com/research/Markets

[DamnYankees]

RG, many have and will continue to be "had" here, except those that made the 30 mil selling just prior to and through ADcomm that is. Anyhow, is Loe referencing the limited can't/wont have Cystectomy population when he explains his rationale for approval? Seems to me that he is in a sideways, not-gonna-come-out-and-directly-say-it kind of way. Then again have long forgotten the BLA

[rgonlyfactspls]

DamnYankees....Hopefully not "had". Hoping more like "to hell and back". I think Doug's rationale is per the paragraph quoted at end of post. I also think it very likely there will be a limiting or narrowing of the indication for MCNA. If it is as Doug Loe suggests (which seems pretty broad) or for just CIS-containing disease and/or other terminology suggested...tough to

[DamnYankees]

analyst mentions this subgroup: those patients "No longer responding to BCG, but would prefer to delay removal of the bladder, if possible". Is that the original indication for the BLA, or is that the unwilling/unable to undergo Cystectomy "limited" indication? Maybe DL has been reading this board and thinks this idea made sense. Maybe I'm misreading that statement