TELESTA THERAPEUTICS INC T.TST

That's the 2nd time TST has used "actionable" in PR re FDA

[LittleLadyPhD]

Actionable: first meaning: giving sufficient reason to take legal action. So I'd love to see a class action suit filed by NMIBC patients vs. FDA for withholding access to MCNA (better efficacy than current 2nd-line therapy and fewer side-effects) during an ongoing global BCG shortage. I'd like to see how the FDA would explain that no, we can't allow you to have MCNA although a P3 study that we designed and approved might give 25% of you extended remission (ie >2 years) or prolong the time you can delay having cystectomy because of politics, or red tape, or national pride. Yep: that would be hard to defend.

[2j3kl]

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[DamnYankees]

Actionable: the use in this context is whether or not there is a sufficient probability of success to act upon. As in "is it worth moving forward and do we have time, resources and ability to act towards a successful conclusion". In simple terms, the FDA may throw the entire file in the garbage and ask them to start over. That is not an "actionable" outcome. 

[1wascallywabbit]

Damn. ...that is my guess as well. Then some USA company picks up the spoils for peanuts and brings MCNA and its devivatives to market in 3-5 years and we get nothing. Then Telesta buys another company or drug with their cash and starts their gravy train over from scratch diluting us to 600 million shares in a couple years and we are left poorer than ever. Anything better than that would be a

[DamnYankees]

Well I have no real opinion on what Monday holds. I do know that recent history says that Telesta is way, way outta their weight class whenever they interact with the FDA and shareholders pay the price. The comment on the term "actionable" is merely an example of what I think they mean when they use it. I don't think that they are inferring a lawsuit against the fda is in the oven

[LittleLadyPhD]

I was expressing my frustration with the fact that the FDA isn't a conduit or filter for safe and efficacious drugs anymore (if it ever was). It's become a politically/financially motivated bottleneck preventing access to life-saving molecules unless they're manufactured by American big Pharma. I get the jargon-y useage of "actionable". I wish it were otherwise. Patients are

[andech]

The FDA decision is not set in stone. We are far away from that.  Or they will find a compromise feasable for both parts. Or TST could appeal the agency's decision after the meeting. The instrument herefore is called "supervisory review" if I am correct.   Epigenomics (OTCQX:EPGNY)did that successfully. They have got the FDA approval yesterday after appealing