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THANKS!!!!! Yes I get it LOL LOL
LOL LOL Havent posted for a while did thus thing hit $1?????? LOL
Lol I think I will believe dr pazdur lol
It is a silly argument, as Pazdur himself notes there is a trend toward more acceptance of ECAs, it s not the case yet in oncology, That and other methodological issues with the study will likely make FDA approval difficult at best
Nope that is completely false
Hmmmmm seems likes a summary from someone with a strong bias
Gee thanks for that lol lol
And don’t forget the key word supportive when talking about eca. We would not want to contradict dr. Pazdur
Three trials ? Ah ok what phase were the other two and what are the final patient numbers in these trials ?
Lol lol nonsense .
These fda approvals for p1 p2 etc. how dies fda do that ? Show us the firm they use
It is important that one reads the WHOLE article';
Based on our search criteria, we identified forty-five products12 (see Table ?Table2)2) for which pivotal trials were supported by external controls.
NOTE; That means ECAs were NOT the primary basis of approval
nonsense, there is no new guidance regarding ECAs. RWE is NOT the same as ECA. Still waiting in yesterday's claim that 45 drugs were approved using ECAs. LOL LOL
Total nonsense
Nonsense there are smaller p1 studies but the larger p3 used ecas that is one of the central issues re interpretation of the results .
Wait.You said 45drugs were approved using eca s that is flat out wrong . I am just pointing out the facts . I understand the fda
lol total gibberish
Supportive is the key word I would be happy to explain this further. So still waiting for that list of 45 lol lol
Lol better read that more carefully lol lol
Pazdur 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.
this is on the article you posted. LOL LOL so perhaps one might to reconsider your statement that 45 drugs were approved using ECAs. LOL LOL
hysterically funny
Rwe is not the same as eca. Sheeze
Wow 45 approved . Why did pazdur say zero lol lol
total nonsense none were approved on ECAs
Lol tell us the approvals
Lol let us know how many oncology drugs were approved on the basis of studied using eca
Yes it was at approved by fda and they agreed they did not mandate the crossover. They would not have approved otherwise thanks lol lol
Lol the keytruda trial that nwbo has zero to do with . I would say it Is not a topic to discuss
But more importantly the sap said otherwise and oh boy those stat people are so precise
Actually it appears fda did not demand the crossover
Maybe but most of the patent has been gutted
ooops
Claims 45-49, 51, 52, 55 and 57 are pending in the application. Claim 49 has been amended. Claims 1-44, 50, 53, 54, and 56 are cancelled. Claims 45-48 have been previously withdrawn. Claims 49, 51, 52, 55 and 57 are currently under consideration.
Nope I am just now reviewing but I already have s legal opinion that is bullshit lol
yes I will examine the file wrapper
has the patent app been published? if so do have have an app number?
like most stuff around nwbo, we now seem to have a mystery combo patent, No one seems to have seen it, no one can reproduce it, no one know exactly what is the basis for this "patent" lol
total bullshit. What vetting by BMY, for example
lol we already know all that. again, no information on the so called patent, which is in and of itself fascinating , maybe the company is do desperate that are hanging on to anything they can, eve if not involved LOL
we already know that there is a combo study that nwbo is not involved in, what doea that have to do with a patent filing?
what combo patent? what request to expedite and what is the basis of any request to expedite??? the uspto doesnt really care about the share price
and he is probably working with the shorts LOL LOL , Hey, maybe he is related to AF .....
wow, this is getting ridiculous