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Nektar Therapeutics (NKTR) Message Board

hoyas012 3 posts  |  Last Activity: Jan 25, 2014 1:27 PM Member since: Sep 30, 2003
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  • hoyas012 hoyas012 Jan 25, 2014 1:27 PM Flag

    Neither FDA nor AZN was blind to the cv issue when AZN's studies were pre-cleared with FDA. After all, the Entereg issue is almost a decade old. I think FDA is going to have a very hard time justifying a non-data-driven, purely speculative, class-killing decision, when NKTR has generated a robust body of safety data that actually trends favorably to control. But we shall see.

  • hoyas012 hoyas012 Jan 25, 2014 12:42 PM Flag

    DCX,
    Respectfully, I think it is naive to suggest that FDA is immune to political and industry pressures. Of course they are not going to ignore an obvious safety signal. But that is not the issue here. The issue, instead, is what will they do in a case where: (1) a sponsor (AZN) has run an extensive phase 3 program showing no safety issues, based on a protocol it cleared with FDA (2) FDA gave instructions to a subsequent sponsor, CBST, regarding additional monitoring it would like to see done on cv issues to render the drug definitively approvable, based on an ambiguous signal generated with a different drug's clinical program, (3) CBST proved unable to enroll studies using these burdensome criteria, (4) patients are suffering on treatments that do not work in this class, and said patients have been proven to benefit from the nktr drug, (5) no sponsor is willing to conduct a cv outcomes trial, and thus it is clear that ordering such a trial would ensure continued suffering for said patients and kill the class, (6) the AdCom has been moved to a division of FDA that is more inclined to balance the suffering side of the equation with the risks, which are non-evident to begin with for the nktr drug. You have a tendency to focus on the negative prongs of the above, but I believe when you view the fabric as a whole, a positive picture emerges for the nktr drug. Nothing is certain of course, but I peg the odds at 80 percent that there will be continued monitoring required as a condition of approval, but no outcomes study under these circumstances.

  • hoyas012 hoyas012 Jan 25, 2014 10:42 AM Flag

    Keep in mind the AdCom has been transferred to a different division. Keep in mind also that the fact that FDA will now have to weigh the fact that it's preferred monitoring criteria have been deemed unimplementable by the one sponsor that attempted to do so. FDA will plainly have to weigh that fact. Clearly, we are in much better position this week than we were last week, when, unbeknownst to us, a rival was marching along in phase 3 with a CV monitoring program that was apparently more robust than that of NKTR. This would have given FDA the easy out, and AdCom could have just said we're going to wait for CBST. Now, they no longer have that out, and they truly will be killing the class if they do not approve NKTR/AZN on the basis of a phase 3 program that they had clearly represented to AZN at the time would be sufficient. I feel a lot better with this announcement out there -- really squeezes FDA hard in the direction of approval.

NKTR
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