GOOGLE : Five FDA Approvals and Reviews at Risk Under a Government Shutdown
By Jon C. Ogg | 24/7 Wall St. – Mon, Sep 30, 2013 10:35 AM EDT
It looks like Congress and the president still cannot figure out how to play well with each other, and now we have another impending government shutdown. The reality is that some government offices will shut entirely and others would run on skeleton crews. You might not get government economic reports until things return to normal. One other big risk is the U.S. Food & Drug Administration. It turns out that several pharmaceutical and biotech drug candidates have pending FDA reviews in the month of October.
In the first three weeks of October various FDA reviews are due for Pfizer Inc. (PFE) and Ligand Pharmaceuticals Inc. (LGND), followed by Antares Pharma Inc. (ATRS), Amarin Corp. PLC (AMRN), one for pSivida Corp. (PSDV) and Alimera Sciences Inc. (ALIM), and a final one for AMAG Pharmaceuticals Inc. (AMAG).
pSivida Corp. (PSDV) has a review of ILUVIEN for the treatment of chronic diabetic macular edema (DME). The FDA accepted a resubmission of this from Alimera Sciences Inc. (ALIM) of the new drug application for ILUVIEN for DME, with a PDUFA date of October 17, 2013. Alimera has been granted marketing authorization for ILUVIEN for DME in six EU countries, and it already has began the commercial launch in Europe. Please note on this that a press relations person wanted to clarify as follows: "Alimera has licensed the delivery device from pSivida, and Alimera is the company that developed and submitted the new drug application for ILUVIEN to the FDA. pSivida has not been involved in working with the FDA on the review of ILUVIEN." pSivida has a share price of only $4.10, and a 52-week range of $1.17 to $4.28, with a market cap of only $95 million. Alimera trades at $3.72, with a $117 million market cap, and its 52-week range is $1.26 to $5.69.