Does this imply that Alimera currently will receive an 'incomplete' grade on its Iluvien application with FDA -- until this study is finished? There's NO WAY that they have data from this September study yet. Is this old news or just an 'oops, forgot to tell you' from ALIM today?!!
>>On November 3, 2011, Alimera Sciences, Inc. ("Alimera"), pSivida Corp.'s licensee with respect to ILUVIEN�, issued a press release providing the following information: "In September 2011, [Alimera] enrolled its first patient in a physician utilization study of its intended commercial inserter for ILUVIEN. The study was initiated in response to a request from the FDA to ensure physicians have a proper understanding of the instructions for inserting the ILUVIEN micro insert into patient eyes. [Alimera] has enrolled 54 patient eyes to date in this study, evaluating the safety and utility of the commercial version of the inserter for ILUVIEN, and is targeting to enroll 100 patient eyes before commercial launch." Data from this study may be required by the FDA for its consideration of the approval of ILUVIEN.<<
full link: ht tp://biz.yahoo.com/e/111103/psdv8-k.html
Appreciate any thoughts. I've been long PSDV for a while now.
good luck -
It means you are screwed.
The FDA will not approve until the study is completed.
It will take another 3 months just to enroll the required patients, then probably 12 weeks for the trial and a couple of months to evaluate the data and then resubmit the NDA and then the FDA will have 60 to 90 days to respond.
It looks like a year delay.
Great news longs! This indicates that the FDA is fine with the drug (the most important thing) and just wants to make sure physicians know how yo administrate Iluvien. My guess is flat out approval or approvable letter. 10$+ either way!
Pay off your basis and keep what shares you can. If you can, hold for six months and this little gem will be acquired, what they are approving "is" the delivery. It will apply to all drugs delivered anywhere in the body going forward. Do the math.
My gut says came up as part of labeling discussion and maybe an in-depth analysis of some subgroup of complications. Label discussions are typically very very important and take weeks. I would expect fairly quick enrollment and analysis. My guess is conditional approval with little delay to commercialization . Study 50% enrolled in 2 months.
I am sure the shorts may try....
These are details as to how practitioners will effectively deliver the drug. If the FDA is requesting this, then it is approved and the details are in the practitioner delivery concerns. These doctors are in fact "doctors". I don't think the delivery is so complicated, but perhaps they want to get it right. I like it and it's a great sign for longs.
it sounds like a study they may want pre-/post approval,and may want ongoing data to date.
<<<The study was initiated in response to a request from the FDA to ensure physicians have a proper understanding of the instructions for inserting the ILUVIEN micro insert into patient eyes>>>
this statement stands out for me!positive..imo
MICKY'S..posts seem most worthwile to read on this M/B--thoughts from mick
disc;bought a small block couple days ago
Sounds to me like we are looking at a delay in getting an approval decision by the FDA - this would be worst case, but we should be prepared for a delay (and probably negative stock price response in the short-term).