nmbr1stckpckr,
I am as anxious as you are in seeing our results, which, as you wells say, will be similar to the "anecdotal" ones or even better as these patients probably will be in better shape to start with.
However, FDA will ONLY look at the results of the trial. Nothing else.
We must remember that this is P2. FDA can come and say: "well done CYDY !!!, now I want P3 with 400 patients. Please report to me back when you are done ...".
Of course, this is not what we all want. Why?? People are dying every day .. here in USA and overseas.
What we want is FDA to say is: "your results are extraordinarily good, we will approve the drug with the condition you do a P4 while you are using it"
So, how do we get extraordinary results ?? We need to show them that the cohort was of good size. 75 patients is not a large sample, therefore reducing it will imo detrimental to the "punch" that the data will bring.
My only point is: a couple of more weeks to achieve full enrollment is a good "price" to pay for a good kick in FDA's butt so they don't have a place to hide once the data comes out
But I hear you, you need the approval soon so more people can be treated (I am wholeheartedly with you), and you are using a good logic, but that is precisely the point: is FDA logic ???
I am afraid not.
I am as anxious as you are in seeing our results, which, as you wells say, will be similar to the "anecdotal" ones or even better as these patients probably will be in better shape to start with.
However, FDA will ONLY look at the results of the trial. Nothing else.
We must remember that this is P2. FDA can come and say: "well done CYDY !!!, now I want P3 with 400 patients. Please report to me back when you are done ...".
Of course, this is not what we all want. Why?? People are dying every day .. here in USA and overseas.
What we want is FDA to say is: "your results are extraordinarily good, we will approve the drug with the condition you do a P4 while you are using it"
So, how do we get extraordinary results ?? We need to show them that the cohort was of good size. 75 patients is not a large sample, therefore reducing it will imo detrimental to the "punch" that the data will bring.
My only point is: a couple of more weeks to achieve full enrollment is a good "price" to pay for a good kick in FDA's butt so they don't have a place to hide once the data comes out
But I hear you, you need the approval soon so more people can be treated (I am wholeheartedly with you), and you are using a good logic, but that is precisely the point: is FDA logic ???
I am afraid not.
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