PSDV (MC $95 M) FDA Decision on October 17 - LOW FLOAT 11 M = RALLYYYYYYYYYYYYYYYY
This Low Float Rocket will hit $6++ before FDA decision on October 17 ...PSDV will move into double digits easily with FDA approval for Blockbuster Candidate Iluven .There is NO FDA approved drugs for DME (Diabetic Macular Edema) .
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.
Pfizer is third largest Shareholder of PSDV holding 1.9 M Shares . PSDV is very close to profitability .
Market Cap: $90 M
Cash: $21 M
Shares Out: 26.8 M ( 10.4 M shares held by Insiders & Institutions)
“We are very pleased that the FDA has accepted Alimera Sciences’ recently resubmitted New Drug Application for ILUVIEN® for chronic Diabetic Macular Edema (DME) and has set a PDUFA target date of October 17, 2013." 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.
The injectable, sustained release micro-insert ILUVIEN® for the treatment of chronic DME considered insufficiently responsive to available therapies, licensed to Alimera Sciences, Inc., has received marketing authorization in Austria, France, Germany, Portugal, Spain and the U.K. and is awaiting authorization in Italy.