FDA Delays Approval of Iluvien to Treat Diabetic Macular Edema
January 4, 2011 Submit Comments Irv Arons
I wrote a comprehensive report about Iluvien and the status and promise of other sustained release drug delivery systems (Iluvien and the Future of Ophthalmic Drug Delivery Systems). At that time, Alimera Sciences, the company developing Iluvien (under license from pSivida) had filed a new drug application (NDA) to treat diabetic macula edema (DME). The company obtained priority review status for the NDA at the end of August, raising the expectation that an approvable letter might be obtained by the end of 2010.
However, instead of an approvable letter, Alimera Sciences announced in late December that it had received a “complete response letter” (CRL) from the FDA, communicating to the company that its NDA application “cannot be approved in its present form”.
The good news is that the FDA did not request any additional clinical trials, only that it wanted additional data and analysis from the company’s two clinical trials (the FAME study) conducted with Iluvien. The company had submitted 24 month data from the studies in its NDA and the FDA wanted an additional 12 months worth of data, out to month 36. The 36 month FAME study was completed in October, and the company is currently in the process of compiling the data requested by the FDA.
According to data I have seen, based on an analysis of the 30-month results of the FAME Study, the company should have no problem filing the new information with the FDA and eventually receiving its marketing approval – however, probably with a year’s delay.
For the rest of the story, including a look at the 30-month data, please follow this link.
You are wrong. They were already finishing up on the remaining months of FAME that the FDA requested when they were told to submit that additional data (as well as fix their supplier problems). They made that submittable and then the latest CRL required 2 more studies which ALIM has not started nor will they at $75KK and 2 years of waiting!!
I am holding 30,000 shares waiting for a buyout by a big Pharma. Europe now and FDA in 2-3 years with a big Pharma footing the bill.
Alimera plans to meet with the U.S. Food and Drug Administration (FDA) during the second quarter of 2012 to discuss the complete response letter it received in November 2011 from the FDA in response to Alimera's New Drug Application for ILUVIEN for the treatment of DME associated with diabetic retinopathy.
PLus, "We expect to receive marketing authorization in each country by the end of the first quarter."
IF??? DOUBLE?? Really, why would you put yourself out on a limb like that 'stocktrader'? It should already be at $8/share.
It was $8/sh prior to the the latest CRL failure by the FDA.It's now half that with European approval for essentially the same size market as the US; double what it was before that approval. There's your double.
But if its the same market as the US, shouldn't it be trading at MORE than the $8/sh it was at before the FDA CRL?? Then double again after FDA approval in two years?
There is something we don't understand still holding this down.