Cash till 2015 EXCLUDING $25 M Milestone payment upon FDA approval expected in mid 2013
and EXCLUDING Iluvien revenue from Europe starting in 1Q 2013 .
PSDV has a very low Burn rate of only 6-8 M a year means this Goldmine will reach profitability next year with the upcoming Iluvien revenue .
Upon US approval of ILUVIEN, pSivida would be entitled to receive a $25 million milestone payment from Alimera and 20 percent of net profits, as defined, on sales of the drug by Alimera.
DME is a potentially blinding disease that affects over one million people in the United States. Currently there are no FDA approved drugs for the treatment of DME.The U.S. market for DME is $1.5 billion to $4 billion.
FDA dumped ILUVIEN twice on both safety and efficacy and have asked for new trials.
Alimare have not made these. Instead, they have chosen to use the same data that is already rejected by the FDA and just compile these into a different worksheet.
I appreciate your total Commitment to PSDV but you have shown to be more than plain naive if you believe that the FDA will approve ILUVIEN on the basis of the existing data. This approval would require new studies and money to this which Alimera do not posses. Therefore, the stock is trading at less than $ 2 per share, despite FDA application in the next quarter.
But no matter what PSDV is a strong buy at current level.
Hi Bohnielsen. Your prediction of an FDA rejection seems a little fast to me. Aren't you too quickly discounting the fact that Alimera had discussions with the FDA about this resubmission and is apparently now going with a narrower target patient population that is the same as that approved in Europe? Don't you think the FDA told Alimera that they would seriously consider this new submission in light of the European approval? Aren't you also discounting the European approval itself? It seems to me that that European approval should cause a very serious review of this new submission by the FDA. After all the European approval provides a backstop for any FDA action and the FDA will not lightly dismiss what their peers in Europe have approved.