The Snow Man
One must have a mind of winter
To regard the frost and the boughs
Of the pine-trees crusted with snow;
And have been cold a long time
To behold the junipers shagged with ice,
The spruces rough in the distant glitter
Of the January sun; and not to think
Of any misery in the sound of the wind,
In the sound of a few leaves,
Which is the sound of the land
Full of the same wind
That is blowing in the same bare place
For the listener, who listens in the snow,
And, nothing himself, beholds
Nothing that is not there and the nothing that is.
FDA does not have to "change the bureaucratic process", they just have to approve rolling review of the NDA. Go to the FDA web site and search "rolling review".
I wonder what they will say about the status of enrollment in the AD trial? Also, anything about the upcoming meeting with the FDA.
Can you smell your own small intestine with your head that far up there?
Have you been diagnosed with prostate cancer? There are things other than prostate cancer that can cause a rising PSA.
If i remember correctly, ACAD is scheduled to meet with the FDA this Spring. I hope the meeting will result in an announcement that FDA agrees to rolling submission of the NDA, starting immediately and finishing with stability data in late 2014. Perhaps allowing accelerated NDA approval in early 2015.
right - not a candidate for "no Phase III" approval by the FDA. But promising enough to take into Phase III, at least on a partner's money.
Is there any evidence that this drug does indeed prolong life?
I think they are scheduled to meet with the FDA this spring. After that meeting, I expect they will announce an FDA-approved plan for rolling submission and accelerated review of the pima NDA, with approval possible in early 2015. If so, you do NOT want to be out of the stock!