TELESTA THERAPEUTICS INC T.TST

The More I Search, the More Mind-Boggling the Adcom's Decis

[SteveMcM1]

ion to vote against MCNA becomes. A quote from the FDA:

"As for FDA, although there may be problems with the clinical trials intended to support a sponsors original proposed indication, if a compound has activity its incumbent on us to work with the sponsor to try to get the drug to the public for areas of high unmet medical need, Office of Hematology and Oncology Products Director Richard Pazdur said in an interview."

Here is what I find extremely interesting in relation to the above quote. In 2015, the FDA approved Farydak to treat 3rd line plus multiple myeloma patients, after the Adcom voted against its approval.

I currently work in pharmaceutical forecasting for a company who is a major player in the multiple myeloma space. There is a MUCH higher unmet need in the bladder cancer space than in the multiple myeloma space; the comparisons are not even close. At the time the FDA went against the Adcom’s recommendation and approved Farydak, the following treatments were available and had long-standing successful histories in treating multiple myeloma:

Velcade - frontline therapy
Revlimid - relapse/refractory
Pomalyst - third line plus
Kyprolis - third line plus
Thalomid - very rarely used but available
-------------------------------------------------
Daratumimab - phase III clinical trials were ongoing in 2015
Elotuzimab - phase III clinical trials were ongoing in 2015

My point of posting this is just to show that Farydak was able to get approved after an FDA adcom rejection, with all of the above treatments available!! There has been nothing in the bladder cancer space since God-awful Valstar in 1998!!! This defines high unmet medical need!!

[Brouwie]

Good read, '' If a drug has activity, its incumbent on us to work with the sponsor to try to make it available for patients with high unmet need, OHOP Director Pazdur said.''

[thathurt]

steve, nice post re. Pazdur and you likely know this more than i but Pazdur is the most powerful person in the FDA as best i know... ..i have seen him only in one AdCom and he came in as "special" guest assasin, and he took the time to destroy the company, the drug candidate, the trial, the science team, etc...he came as close to calling them a fraud as you could ..after the company

[rgonlyfactspls]

thathurt...that is interesting. However you left out one small detail...the Company you are referring too (unless I missed it in all the cryptic text). Pls provide and possibly include link. Thank you.

[thathurt]

rg, their name is irrelevant that is why i didn't and won't post it (AdCom vote was 100% no) it is the narrative that is important and it is this if the FDA wants to bury you (and it is based on science not some malice agenda) they will and they do..they were IMO broadly supportive of MCNA and i base my opinion on previous experiences where they weren't of other therapies and current

[rgonlyfactspls]

thathurt, thatconfusing. Now you convey in a positive light, Pazdur is"a 2013 ASCO Hall of Famer" after just conveying he/Pazdur was a "special guest assassin". Then, in recent your post to DamnYankees you speak of " jump into the rabbit hole / Alice in Wonderland". Were "you" speaking to Alice last night???... https://www.youtube.com/watch?v=Vl89g2SwMh4 ---

[DamnYankees]

RGF, you might have misread Hurt. I did not interpret his message that way, although I think I see where you got tripped up. Worth reading again. On a board that has too many " The Government has a tracking device planted in me" types, don't discount the few intellects that bother posting here. Whether you disagree with them or not.

[thathurt]

damn,  you are correct rg did a complete misread..was his misread intentional or not, who cares not me...but i will provide some folks a "rabbit hole" story....so AdCom, which IMO is supposed to be a high-end, data driven science party, seems to state very strongly that MCNA was safer than BCG (a very positive statement and i could see a non-negative endorsement (like it seems

[DamnYankees]

I had many of these rabbit hole conversations in college. Very intelligent conversations, with guys who would up being multi multi millionaires of different sorts later In life. The difference is we were smoking Turkish hashish and didn't have human lives hinging on our senseless  intellectual bender. I get the rabbit hole analogy.

[rgonlyfactspls]

DamnYankees... Just know I asked thathurt a very simple request... "name of company". If post was the truth, easy enough to do, and can't believe any concerns as all now history if I recall. Maybe later will un-ignore and re-read the post(s). Thanks for the fyi. rg

[thathurt]

damn and others, who can and are interested to further your understanding of FDA/AdCom..on NOv 24 BMRN is doing the AdCom thingy.. i suggest tuning in for the FDA presentation...IMO BRMN presentation is irrelevant as they will be trying to put lipstick on a pig to call it a silk purse to sell it to a Martian...but IMO i expect the FDA to destroy BMRN in their presentation, so listen to it and

[DamnYankees]

Of all the concerns here, I don't think misrepresentation is one of them. Unless you consider refusing to properly address the question at hand, within defined parameters provided by the FDA as a misrepresentation of objectivity? You guys seem knowledgeable. Far more than myself and others. while little was provided in the Telesta NR they did note that they will be consulting with Ipsen. What

[DamnYankees]

Further to my post, and admiringly knowing little about Ipsen, are they a potential US partner. Their website says that they have direct representation for their Oncology products in 30 countries including all of Western Europe but not US. Telesta has knife to their throat by forgoing a US Pharma partner, who would have easily slammed the door on that wasted Advomm discussion. can Ipsen be a US

[DamnYankees]

Correction -Admittedly not admiringly and I am unclear whether Ipsen has direct US representation for their oncology lineup. I know a product that they can start with though if prepared to provide the necessary horsepower to get MCNA it's just approval

[thathurt]

damn, IMO the FDA was very supportive of TST's data and package, my point was if they are not they will let you know in no uncertain terms...that is what you get from FDA briefing documents, they did their independent work and came to the same conclusion ..AdCom is a different animal and i again state that to me the FDA was supportive of MCNA even in the AdCom meeting (as a comparable tune in