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  • mikerconfer mikerconfer Dec 13, 2012 3:56 PM Flag

    EU Approval

    I know we're all looking for notification of EU approval, given that today was the final day of the monthly EMEA/CHMP meeting. Everyone should keep a couple of things in mind:

    First, if you are looking for information on the EMA or CHMP websites, you should be searching on "pegloticase" NOT "Krstexxa".

    Second, even though the monthly meetings are concluded, it may be days before any approval posting is made on the EMA site. It's not completely unlikely that Savient will release an approval notice via Global Newswire or some-such before the EMA gets their site updated, particularly this time of year.

    Third, the infamous "67 Day Clock" really isn't a cast-in-stone deadline; notification could actually happen well after (or in somewhat rarer cases) somewhat before that time frame, which in this case would be December 24. My best guess is that it will happen by the 21rst or else it will not happen until after the first of the year. I lived in Europe for awhile and trying to get anything but some fairly heavy partying done in government offices around the Christmas holidays is pretty much a lost cause.

    Lastly, I understand that it is extremely rare for the EU to not approve a marketing authorization after a recommended approval from the CHMP, so the very great likelihood is that Krystexxa will be approved for sale in the EU in the near term. Don't stress over the next several days. Enjoy your holidays.

    As usual - Hold 'em if you got 'em; Buy 'em if you don't.

    Peace to All and have a Happy Holiday.


    Sentiment: Buy

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    • The 67 day clock is mandated by European law, and includes 15 days for the cmhp opinion to be delivered to the EU commission, which usually doesn't take that long unless the applicant requests to make label changes.. The clock is a maximum thus a decision is likely to be released before it is up. Just look at previous drugs that have been approved. I'm sticking with my no later than Monday announcement of EU approval.

      • 3 Replies to iamdeebo831
      • I went ahead and double-checked this. The CHMP recommendation for approval is circulated (with supporting data) to the member states of the EU for a 15 (not 16 as I erroneously stated - don't know where the 16 came from but it must have been some other regulatory provision) day review cycle. The "67 Day Clock" however, is not mandated by statute; it is a guideline provided for by the EMEA whose restrictions are far more binding on the applicant than on the Agency itself, hence the CHMP's guidance that European Marketing Approval will "normally be granted within 67 days of issuance of a favorable CHMP recommendation".

        Absolutely not trying to rain on anyone's parade here - those who know me on this Board know that I'm long more than 20,000 shares that I'd just LOVE to turn a profit on. I am a BIG fan of realistic expectations though, as opposed to the ones that folks on the short side of the trade make so much hay over.


        Sentiment: Buy

      • The 67 day clock is a "guideline" not a requirement, Per the CHMP approval will "generally" be made within 67 days.

        Sentiment: Buy

      • YIKES!!! Monday!!?? I'll have to buy a NEW suit for the occasion!!


        Sentiment: Hold

    • Once again THANK YOU Mike for your astute research. Some of us don't have the expertise to put these pieces together. Pleased to have you in the Brain Trust.

      Pleeeeezzzzzzz let it be January or sooner, got a project I want to do with some of the profits.

      I was just going over again the 5 & 10 year charts, plus all the coresponding technicals. There is no room but UP, and this can REALLY fly, provided we get some wind behind it. Might be able to squeeze some more shares out of my paycheck next week.

      Sitting on a LOT of potential here. Plus my VRNG shares are pretty much doing the SAME THING waiting on news, and getting abused daily by the Short folks.

      Sentiment: Hold

      • 1 Reply to dkguardthetruth
      • I'm with you there, dk, but as others have noted elsewhere the real catalyst will be partnership rather than the approval itself. Savient really doesn't have the resources for a full court press in Europe, and a solid partner (preferably with an up-front payment and a reasonable net sales percentage) is a must-have.

        I think the stock will get a nice bump up from approval, sure, but the real appreciation should happen after partnership.



        Sentiment: Buy

    • EU is a deal done... time to release... maybe HF's and MM's dont move the PPs in time...

      The drug is approved in Spain last month... so European launch is ready!

      • 1 Reply to legosnovax
      • All the EU member states have a sixteen day review of any CHMP recommendation for approval, so no, it's not "a done deal". Any substantive objection CAN overturn or delay marketing approval. Is approval LIKELY? Yes, I'd say it's extremely likely. Is it going to be communicated before the first of the year? That's a bit more questionable.

        I'd love to see it as soon as possible, of course, but I never count my chickens before they hatch.


        Sentiment: Buy