From Wedbush – saying the same thing as Goldman
“Moreover, we note that the term “minor” is often a misnomer with respect to deficiency letters. For instance, MNTA itself received a “minor deficiency letter” with respect to its immunogenicity data, an issue which eventually took MNTA a full 18 months to resolve to the FDA’s satisfaction. Indeed, for truly simple issues, the FDA has created a telephone amendment pathway through which these issues can be resolved. The FDA’s decision to not employ this telephone amendment path suggests that substantive issues do remain for TEVA.”
One other bullet
"TEVA describes the issues as minor, but company’s track record is questionable here. TEVA’s press release appears to portray the unresolved issues as relatively insignificant and easily resolved. However, we caution investors from taking this at face value: Recall that upon MNTA’s approval in July 2010, TEVA responded by saying it expected to receive approval of its own generic Enoxaparin in late August. When August passed with no approval, the company then stated that it believed an approval was imminent in the autumn of 2010. When that failed to materialize, TEVA said it would be “disappointed” if they did not receive approval by year end. After failing to receive approval in 2010, TEVA disclosed at an analyst conference earlier this month that the FDA would provide a response by the end of this month, and that TEVA expected the decision to be an approval. While TEVA describes the FDA’s letter as having a short-list of minor issues, we note that the company has a growing history of being unrealistically optimistic regarding the timing of approval. In our view, TEVA’s past history raises the possibility that the unresolved issues could be more substantive and take longer to resolve than TEVA’s press release suggests. That said, because the public is unable to review TEVA’s ANDA itself, it is impossible for us to say with any confidence that approval will never occur. For this reason, we continue to expect approval in Q4:2011."
