.....pSivida Corp. (PSDV)
¡atentos! ... rebota en premercado +58,00%
Wednesday, Dec 18
4:49 PMAlimera, pSivida soar on Iluvien news
Alimera Sciences (ALIM) soars 36% AH.The company and the FDA have entered into labeling discussions regarding Iluvien.An agreement has been reached that the company's participation in a January Ad Com is "no longer necessary."
ALIM says it will "focus instead on drafting its response to the CRL."
Submission expected in Q1 2014.
The company will address manufacturing facility concerns and will "provide a safety update."
Finally, ALIM says it "will not be required to conduct any new clinical trials in connection with the FDA's review of Iluvien prior to approval." (PR)For context, see here.Also higher (of course) is pSivida (PSDV), up 24% in late trading.