Will Teva's Copaxone Ever Get An FDA Decision?

In a report published Tuesday, Susquehanna analysts maintained a Positive rating on

, with a price target of $70, after the company's eighth petition raised further issues of scientific complexity related to Copaxone generics. In the report Susquehanna noted, "An FDA decision to approve one or more Copaxone generics could come at any time, as has been the case since last May. It is unclear what impact TEVA's citizen petitions have played in the FDA's decision-making process, but the status quo is helpful in both the short and longer term as TEVA shifts patients to three times weekly dosing." Teva has recently filed CP#8, or its eighth citizen petition, asking the FDA not to approve any generics to Copaxone "without extensive clinical studies." All other petitions by the company have been rejected by FDA on "procedural grounds." So far the FDA has not provided any substantive response on several key issues, saying that it would be "premature to comment." The analysts expect the FDA to "provide a detailed statement on these issues when/if it approves the first generic."