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Biotech / Medical : MEDX ... anybody following? -- Ignore unavailable to you. Want to Upgrade?

To: A.J. Mullen who wrote (1978)4/25/2008 5:46:23 PM
From: Icebrg  Read Replies (1) | Respond to of 2240
 
I suppose this is sort of good news disguised as bad news. I.e. FDA appears willing to consider OS rather than PFS for approval.

As indications are, that PFS is not a good endpoint for this type of drug the chance for approval may actually have improved.

But it will take much longer. How do they get a meaningful reading of the OS in these trials, when there is no comparator?

Erik


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