Theralase Technologies Inc. V.TLT

Per 012009

[BlueFranky]

"Your thinking they are looking at the data for accelerated approval  AA?

That would make perfectly good sense and could justify the time it took to gather all the long term data 

And having a centralized lab validate that the numbers are so good this treatment should be available to all that don't have any other option left"

... Almost spewing coffee everywhere .. in the best of ways.

...  could it be possible? :-)

[Legit62]

YES

[Longholder99]

 I wonder if the specified lack of side effects and/or quality of life reporting that we arent seeing in the clinical reports could be coming via the extra steps taken by the central lab (reaching out to patients once again) as a way of seeking verification of the surrogate endpoints required for AA approval?  

[CancerSlayer]

It is my understanding that the FDA guidelines indicate that a single-arm trial that demonstrates a competitive CR rate (primary endpoint) & that rate is supported by a durable response provides sufficient evidence of efficacy to support a marketing application/AA.  Any of the other secondary endpoints such as QOL, event/progressiom-free survival, cost, etc. (though important data sets

[BlueFranky]

Thanks for the clarification Slayer. We're irrefutably compelling on both points. Onward and upward!

[Longholder99]

Appreciate the clarity as well.  Either way it does make you wonder if all this extra work and time is a leadership decision we will all benefit from.

[DeathXray33]

Moderna: "The stock has dropped 46% so far this year and 56% in the past three months" Merck: down 19% in three months.

[Alamir1111]

Death x the reason for price drops is due to covid  vaccines sales .Nobody cares about them nor they will be mandated  again .Hope so

[CancerSlayer]

Re: Moderna, the stock has been brutalized recently as viral vaccine demand has decreased, vaccine side effects can be limiting (high inflammatory response with mRNA tech) & mRNA vaccine development/operational costs still run high.  Having said that, its cancer vaccine potential shows promise & the current sp is probably trading at a nice discount for a long-term holder...imo. I'