Replies to post #121387 on Biotech Values

[investorgold2002]

since Q4 2010 or earlier reddy's have been saying fondaparinux approval is imminent..they even stated FDA inspection of their fondaparinux plant was done...and keep in mind, fondaparinux has "priority" review..this is where the wheelerspeak hits home. I am very skeptical on copaxone approval within next 6 months..It's sounding more like at least a year. It;s interesting that fondaparinux received a priority review(dont know the basis?) by FDA. One would think copaxone being such a heavily used product, would also necessitate a priority review.

[investorgold2002]

"As we understand it, the review time for non prioritised ANDAs is calculated from the date on
which OGD receives an ANDA. While we acknowledge that ACL does actually have priority
review, with these timelines not being met we use the current median approval times for nonprioritised
generics to estimate a potential approval date. Based on the May 2009 FDA
acceptance for review of ACL’s ANDA and counting 27 – 30 months from this point, we estimate
approval of ACL’s fondaparinux ANDA between July and October 2011"


This doesn't make sense. On this basis, copaxone should be approved now. Fondaparinux as I understand is in final stages of ANDA approval...FDA inspections everything has been done. I don't think for Copaxone this is done? I wish there was greater visibility on the timing of FDA