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Bullboard - Stock Discussion Forum TELESTA THERAPEUTICS INC T.TST

"Telesta Therapeutics Inc is a biopharmaceutical company. The Company is engaged in the research, development, manufacturing and commercialization of human health products and technologies."

TSX:TST - Post Discussion

TELESTA THERAPEUTICS INC > Donald's Email Response
View:
Post by JPMUSSE on Nov 26, 2015 11:18am

Donald's Email Response

Thanks for your notes – needless to say, it has been a very busy week.  
 
I cannot dispute the historical rates, nor can I give you our assessment of our chances.  We do believe that we have good arguments to bring to the FDA to consider approval, notwithstanding the AdComm vote, including their own analysis in the FDA briefing document.  I can say that we were very happy that all but one of the urologists voted yes and that we will be working very hard to achieve a positive outcome.
 
Note that the FDA can approve us for the requested indication, approve us for a narrower indication, approve us with either of these labels but require us to do another clinical trial while we sell and market, or tell us that we need another clinical trial (the worst case).
 
In addition, do keep in mind that we have a strong balance sheet and a strong partner in Ipsen who has rights to MCNA exUSA and Japan.
 
Best regards,
 
Don
 
 

Donald Olds, M.Sc., MBA

Comment by rgonlyfactspls on Nov 26, 2015 11:41am
JP...Thank you for sharing. Certainly has added a tad more detail/ information than in their press release. But, did I miss something re "Japan" or am reading the last sentence incorrectly re Ipsen and Japan? Quoting your email from Donald Olds..."In addition, do keep in mind that we have a strong balance sheet and a strong partner in Ipsen who has rights to MCNA exUSA and Japan ...more  
Comment by HighteawithIntrepid on Nov 26, 2015 11:57am
Ok once again: we have a partner for Korea we have a partner for Canada Mexico in Palidin  we have no partner for Japan  we want to control marketing in the US and have no partner there ipsen has the rest of the world 
Comment by Junit on Nov 26, 2015 12:02pm
Based off of the ipsen deal is it not a decent spec that a Japanese partner and eventual deal in the U.S would have huge implications to the current market cap? I like the balance sheet and I like a depressed share price that just touched multi year support today. From a speculators point of view it looks as if the selling/stop loss investors have capitulated. If they don't get fda sure there ...more  
Comment by SupermanLantern on Nov 26, 2015 12:02pm
Don't forget South Africa
Comment by JPMUSSE on Nov 26, 2015 1:51pm
It is clear from Donald's email that they still have potential Ex-UsA and Ex-Japan markets that they can target. I believe they will not be able to do business in Japan until FDA is on board. He has pretty much laid out all the scenarios which possibly can happen. 
Comment by KingSarloc on Nov 26, 2015 2:09pm
Where can I find this email? from Donald? Is it Donald Trump?
Comment by stockmas44 on Nov 26, 2015 2:11pm
Ronald McDonald
Comment by KingSarloc on Nov 26, 2015 2:16pm
Hahahaha lmao hahaha that's funny but not funny enough.. I lost $150 from this stock
Comment by JPMUSSE on Nov 26, 2015 2:45pm
Here is the context of email from Donald Olds for those who missed it "Thanks for your notes – needless to say, it has been a very busy week.     I cannot dispute the historical rates, nor can I give you our assessment of our chances.  We do believe that we have good arguments to bring to the FDA to consider approval, notwithstanding the AdComm vote, including their own ...more  
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