Upon reading the last few posts, even I was a bit perplexed by what all the Uveitis stuff meant; dates etc. So in my confusion I contacted Bev. I sincerely hope she doesn't mind me copying her response. I tried to pack it all into my brain but that would be a disservice to the information and I would have screwed it up.
I went through the boards (although rather quickly as I was traveling Thursday and Friday). I’m not quite sure what the problem is….there is currently an investigator-sponsored uveitis trial underway (I think at Duke University, but don’t quote me on that until I can confirm that I’m right on this). That is a very small trial, but it recently received approval to enroll additional folks.
Then there is are the official pivotal phase 3 trials for uveitis – as filed on clinicaltrials.gov. That trial is expected to start recruitment this quarter (although it might bleed over to start of next quarter). Given that it will take time to enroll the trial – remember it is two trials with a total of 300 patients. pSivida has said that they will start the first of the two trials – why only start the one – because until we know about the FDA approval or lack thereof, it would not make sense to do two trials at this point. Should the FDA approve Iluvien, then pSivida’s course with uveitis (now being called Medidur) would change and they could seek approval under a different status since there would be the exact same drug approved out there – it would require only one trial rather than two. But again, that’s simply a matter of uncertainty, so pSivida believes it prudent to start the first trial and then see what happens with FDA and Alimera.
All that being said – it will take time to enroll the trial – the FDA has said a one-year follow-up (not two – one year follow up with the endpoint being recurrence of disease). So, I’m not completely sure what people were expecting here….we’ve always said that there will be information on this in the second quarter of this year (e.g. enrollment) followed of course, by additional information as available. If you could help with what might be some of the specific concerns I can try to get answers.
I also have no idea why we’re seeing the weakness in the stock – it could simply be that we haven’t really had any significant news and expectations are out there….but then you know pSivida – they want to be sure every “I” is dotted and every “t” crossed before anything is said.
Just let me know how I can help you guys with clarity if possible and you know I’ll try to get the info for you.