I thought the same first. But they can not allow,
Post# of 155128
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Posted On: 02/07/2020 11:47:32 AM
I thought the same first. But they can not allow, to only get the results from some patients, because then we could do cherry picking.
If the reason is that the FDA want to justify their 700mg label for combo (while combo only used 350mg) with the data from the mono trial, than they have to use all the data.
You cant choose just some results. And if they compare 700mg to 525mg mono they have to check the results on 350mg as well.
But one could asked, on which basis they made the previously 700mg decision. Misiu I think you said before, that they had already the clinical part from mono for review, on which they decided for 700mg.
So if that is correct, and they could base their decision on the data available at that time, than why wouldnt the patient data at that point be sufficent. Why did NP say yesterday, that he couldnt provide that data now, because the trial wasnt finished So why wants the fda that trial to be completed, if they had the data already sufficent for them self to decide on 700mg, but suddenly now not to be sufficent to support there own case for the records?
Strange, that would support the mono label extension theory.
They did the final decision on 700mg, did they? Or could they change now again suddenly to 525mg?
Please correct me if I see something wrong.
Ohm, whats your opinion on Bored Lawyers argument?
If the reason is that the FDA want to justify their 700mg label for combo (while combo only used 350mg) with the data from the mono trial, than they have to use all the data.
You cant choose just some results. And if they compare 700mg to 525mg mono they have to check the results on 350mg as well.
But one could asked, on which basis they made the previously 700mg decision. Misiu I think you said before, that they had already the clinical part from mono for review, on which they decided for 700mg.
So if that is correct, and they could base their decision on the data available at that time, than why wouldnt the patient data at that point be sufficent. Why did NP say yesterday, that he couldnt provide that data now, because the trial wasnt finished So why wants the fda that trial to be completed, if they had the data already sufficent for them self to decide on 700mg, but suddenly now not to be sufficent to support there own case for the records?
Strange, that would support the mono label extension theory.
They did the final decision on 700mg, did they? Or could they change now again suddenly to 525mg?
Please correct me if I see something wrong.
Ohm, whats your opinion on Bored Lawyers argument?
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