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Lol hysterically funny
I should explain that it Is a p1 trial lol lol
Lol the combo trial is a p1 trial
but those other trials are not registration trials
except there was no highly successful P3
based on the 5 year chart, I would have to say NO
been a while. thought i would check in. has this company made any progress?
absolutely correct
what is the current Guidance re ECAs?
so what?
Please post those agreements
Unlikely as they are not pivotalp3 trials . The keytruda is p1
That is vexatious nonsense. No one said a word about it being settled or resolved by now .
No you miss the point the use of Eca seriously weaken the study . Doubt fda will accept it
Strongest design ???? Perhaps the fact that many oncologists don’t believe eca controls
The complaint is just that. It is an allegation . Not fact
Amazing wonderful strongest …… bullshit
Jama onc they should call it jamajunk
So that is not proof of the 99% claim . That is why I didn’t ask lol
I wasnt asking you the question, but do you have the proof??? LOL
do you have proof of that 99% claim ???
not sure why this is recommended as the journal in question is NOT on the list
LOL LOL so, it is not on the list of top journals, Understandably with crappy peer review
hmmmm where is JAMAonc ?????
please provide details on how and when Merck sabotaged. That will be useful info
well, the peer review process seems rather shoddy. Always useful to point out it was Jamaonc.
proven is a descriptor that many oncologists would question
I think the number is 73 lol lol
52.13 LOLLOL
no she said FDA are becoming for open to ECA but did not say that they are acceptable to FDA, She went on to say that she respects the opinions of other oncologists this are of the opinion that ECAs are not valid 52.13 on the tape
that is not correct
yes but ECAs are still controversial and NOT useful for approval . LL said as much last night
I cant find this!!!!!!!!
I was told to look at Final Guidance for ECA. LOL turns out there is NO new Final Guidance for ECA LOL
but not ECA
really? how so???
different question. Bu the way that document deals with RWD/RWE not ECA
LOL as I have explained previously that is a process document, ie if you are going to submist such data, here is how to do it No where does it say that data will be satisfactory, in other words no change in policy
yes it is published . Not as guidance, as Pazdur himself said:
The use of external control arms in oncology is an evolving area of methodological advancement and regulatory interest. Thus far, external control data have been limited to establishing natural history or providing supportive data analyses affording clinical context for an observed treatment effect. These data have not provided pivotal support as substantial evidence of treatment effectiveness in oncology, and therefore have not yet been included in the prescription drug labeling.
notice the word DRAFT LOL LOL