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Nektar Therapeutics Message Board

  • pettitmb pettitmb Nov 15, 2012 9:21 AM Flag

    CV events

    Are we worried about the FDA requring more studies based on CV events? Sure it could happen, however, to date, with not much time left in the 52 week study, HR has let us know what is happening. Past the no imbalance statement, HR plainly described the imbalance to be in fact for the few CV events on the study that have occured more came from the placebo group.

    Is the risk? Always... The reward outweighs the risk with the facts that are known. I have added heavily to my position.

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    • "Past the no imbalance statement, HR plainly described the imbalance to be in fact for the few CV events on the study that have occured more came from the placebo group"

      It would be nice to have the cc quotation on that because it is not readily apparent.

      It is well known that Nalxone can cause dramatic changes in heart rythym and blood pressure when administered by injection in od cases. The concern with oral administration is that it will also affect the Alpha and Beta heart receptors as it does with injection. This concern applies to all mu antagonists and it would be a mistake to be so cynical as to believe that the evaluation committe pulled their concerns out of a hat.

      • 2 Replies to marketmakerx
      • From Rob
        "In terms of cardiovascular events, all events that were reported as cardiovascular were adjudicated by an independent third-party and what we see is a very low overall occurrence of cardiovascular events and actually more relatively speaking in the placebo arms and the act of drug arms. And your third question was around the …"

      • Robert Medve

        The cardiovascular events, and this is Rob. The cardiovascular events are collected throughout the trial, but anytime any event would occur or any adverse event cardiovascular or not is collected throughout the trial. So, these are all regardless of a time of occurrence, it’s not what we recall landmark analysis, where we are looking at the end of 12-week to see if anyone’s had a cardiovascular event. It’s regardless to whether a patients’ responded whether they have not responded, how many doses of drug. If they are on the trial and they’ve reported an adverse event then that is taken into consideration and evaluated in terms of generating the safety profile of the drug. So, will be anybody who has taken the naloxegol or placebo at anytime during the conduct of these studies. So, it’s a very large pool of people who are included in this safety database.

        Birin Amin - Jefferies & Company
        And can you comment on – in the 12-extension, did the placebo patients cross over to the active arm?

        Howard W. Robin - President and Chief Executive Officer
        No that’s not specifically across over trial. It’s just an extension trial.

        Birin Amin - Jefferies & Company
        So, the placebo patients continued on placebo for the second 12-week phase?

        Howard W. Robin - President and Chief Executive Officer

    • I am surprise AZN/NKTR are sharing anything with the ongoing Phase III trial. At this point the only discussion should be with AZN/NKTR and the FDA . NKTR never said any thing about the FDA.

      Why is nktr saying anything???? AZN is running he trial and paying for the trial.. Is NKTR talking to the FDA or is AZN talking to the FDA. or both??

      At Monday PR, it was all nktr?????

      If there was real news, it would be coming from AZN.

      So NKTR released the Q3 earnings Friday, Monday discuss the NKTR 118... Why did that happen????
      NKTR was under a short attack....I think nktr never should have said anything on Monday, refer the analysis to AZN. What exactly did NKTR accomplish???? Hindsight !

      It not like NKTR can restart a trial or change the trial or even add a trial., its all AZN.

      Like anyone is going to share data with a ongoing trial. Something is not right here.

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