PSDV is a good company with a fairly good track record of success.
I played the Iluvien run-up going into the November 2011 CRL.
Management does not seem upbeat about approval without the
additional phase III trials "requested" by the FDA. It is folly to believe
that the FDA is inclined to approve just because they accepted the NDA
for review. Just take a look at the four CRLs DSCO's Surfaxin received
before finally gaining approval. Then, there's dear old HEB. How many
times has Ampligen received a CRL. The drug has been around since
the 1960's. It's been applied to every trendy malady to come along from
HIV to Chronic Fatigue Syndrome, and still no approval. Ampligen has
a PDUFA of February 2nd. It will be yet another CRL. I just dropped by
to see what was moving the stock. It's on one of my watch lists.
I hope the reformatted data will win over the FDA, but, in my experience,
that rarely happens.