Recent

% | $
Quotes you view appear here for quick access.

SAVİENT PHARM AŞ Message Board

you are viewing a single comment's thread.

view the rest of the posts
  • iamdeebo831 iamdeebo831 Dec 13, 2012 9:11 PM Flag

    EU Approval

    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.

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • 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.

      Peace.

      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!!

      CALL THE CATERER!!! WE GOT A PARTY TO PLAN!!!

      Sentiment: Hold

 
SVNTQ
0.00(0.00%)