Replies to post #168408 on Biotech Values

[dav1234]

PSDV $1.75..-53% p/m..ALIM not really trading..eom

[dav1234]

PSDV impressive bounce..ALIM not so much..eom

[DewDiligence]

PSDV/ALIM—I’m not surprised FDA rejected Iluvien again—I think it’s a dubious product (and have been saying so on this board for several years).

Iluvien got approved in the EU because it is regulated as a device rather than a drug and the EU has an astonishingly low bar for approval of medical devices.

[DewDiligence]

ALIM was +63% and PSDV was +35% yesterday on news that FDA will not require a new clinical trial to satisfy the terms of the Iluvien CRL issued in October:

http://finance.yahoo.com/news/alimera-sciences-fda-enter-labeling-213000675.html

An FDA advisory committee is also no longer required.

I didn’t think the FDA would ever approve Iluvien.