working 24/7 for truth and honesty
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I asked for Guidance that is not Guidance , sorry
I was not asking, why would you say I was?
it is NOT guidance
LOL none of that is new Guidance
but to be helpful, right at the top they put the word Guidance lol lol
Clinical Trial Endpoints
for the Approval of
Cancer Drugs and
Biologics Guidance for Industry
did you read it?
strong support can emerge. does that say we rescind the prior guidance. No it odes not.
oh, ok if you have more recent FDA Guidance we would all like to see it
I must have missed the FINAL, pleas repost LOL
I dont see anything about 2020
Our products and our ongoing development activities are subject to regulation by regulatory authorities in the countries in which we and our collaborators and distributors wish to test, manufacture or market our products. For instance, the FDA will regulate our product in the U.S. and equivalent authorities, such as the MHRA and EMA will regulate in Europe and other jurisdictions. Regulatory approval by these authorities will be subject to the evaluation of data relating to the quality, efficacy and safety of the product for its proposed use, and there can be no assurance that the regulatory authorities will find our data sufficient to support product approval of DCVax-L or DCVax-Direct. In addition, the endpoint against which the data is measured must be acceptable to the regulatory authorities, and the statistical analysis plan for how the data will be evaluated must also be acceptable to the regulatory authorities. The statistical analysis plan that we submitted to regulators for the Phase III trial embodies a different primary endpoint and secondary endpoint than did the original Protocol for the trial. Under the Protocol the primary endpoint was progression free survival, or PFS, and the secondary endpoint was overall survival, or OS. Both of these endpoints were confounded: the PFS endpoint by pseudo-progression, and the OS endpoint by the “crossover” provision in the trial design, which allowed all of the patients in the trial to cross over to DCVax-L treatment after tumor recurrence (while remaining blinded as to which treatment they received before tumor recurrence). The statistical analysis plan uses external control patients rather than within-study controls. There can be no assurance that regulatory authorities will allow a product approval to be based upon this approach.
what does fda saY::
Data derived from externally controlled trials are seldom reliable for time-to-event endpoints, including overall survival. Apparent differences in outcome between external controls and current treatment groups can arise from differences other than drug treatment, including patient selection, improved imaging techniques, or improved supportive care. Randomized studies minimize the effect of these known and unknown differences by providing a direct outcome comparison. Demonstration of a statistically significant improvement in overall survival can be considered to be clinically significant if the toxicity profile is acceptable and has often supported new drug approval.
A little bit of it is. But much of it is based on selective listening
Agreed but I was asking how hoff for Examples
NAh you did not provide examples
oh, ok, provide examples where that was the case
who said anything about nvcr , Not me
Ah that changes everything ! The fda wrote that …….oh wait no they didn’t . I’ll wait for the fda version
once was more than enough. the foot doctor is a joke
that might be true if there were a P3 with outstanding rrsults, but alas, there isnt
well it was interesting. she had no warm and fuzzy comments about nwbo and she stammered re the question of atl and dccrap being the same.......... what's up there?
correct???? hmmmmm seems you agree it was not 'smashing"
smashed??? hmmmmm not what savvy investors heard
LOL so no answer to the question, known by what authority ???
no thanks
after the interview with Dr Feet last night all speculation about approval is out the window
known facts according to what authority???
WHAT??? so now, two unrelated events mean the RAs have approved the changed protocol ??? wow that is bizaare
comments on a message board are not facts
LOL I didnt suggest that at all. Once watching dr feet is enough LOL
LOL realize that it is a civil suit, filed by a law firm, not the DOJ
She dodged a lot of questions for good reason
What????better watch Again
Collaborator lol lol
So what even if it were true . It isn’t dccrap and nwbo has nothing to do with it lol lol
Merck is not funding the trial
Nwbo has nothing to do with the combo trial .
no I have zero interest in that trial
LOL as I posted many trials with no crossover
ah i just looked it up.he is a podiatrist lol lol
there is not a shred of proof that they did
as I have just demonstrated they do NOT mandate a crossover
Musella??? remind us, what is his medical speciality LOL LOL