The following is for your reading pleasure. I am still watching ALIM. Seems like a very long time frame for the FDA to enter a verdict. I made money on an earlier trade and may invest in any pullbacks from here:
Citi maintains Buy: * What's New - On Thursday (2/3) after the close, ALIM presented 36-month follow-up data from its FAME trial studying Iluvien for DME (diabetic macular edema). This data is part of a re-filing with data from the 24 to 36 month time period related to the FDA's December CRL, where it did not approve the Iluvien NDA. The data on Thursday were positive and demonstrated that Trial A and B each maintained statistically significant improvement over placebo out to 33 months (p=0.042 and p=0.046, respectively) and therapeutic effect out to 36 months (see Fig. 1). We believe this data supports Iluvien's 4Q11 approval and 1Q12 launch.
* Recent Meeting with the FDA - ALIM met with the FDA on Wednesday and confirmed that it was not required to demonstrate significance out to 36 months to gain approval, which is an important point for investors since the trial's original endpoint was only out to 24 months. In addition, the FDA was not concerned about the MART subset of data which originally missed an endpoint at 24 months. With respect to third party mftg. issues in the CRL, there was no new update.
* Safety Results (Fig. 2-3) - While cataract surgery rates remain high (80% at 36M vs. 75% at 24M), the key issue is IOP-lowering surgeries, which remained low out to 36 months at 4.8% (vs. 3.7% at 24 months)-an important positive.
* Next Steps - ALIM remains on track to re-submit its response to the FDA by the end of 1Q11, after which point the FDA has 6 months to respond (end 3Q11). We believe there is the possibility of an FDA panel meeting between now and 3Q, but we don't view that as a negative.
* Maintain Buy and $12 Target - Our peak rev est. for Iluvien remains $800M in 2018. Target based on an unchanged 2.0x EV/Sales multiple on our 2013E revenues of $270M discounted back 2 years at 25%.