I've written an analysis of Iluvien's clinical trial results and how they relate to its chance for approval. Let me know what you think:
Southern still can't believe FDA rejected again. His nonfunctioning mind is spinning out of control. Spittle is forming at the corners of his mouth. What happened he thinks to himself. Where did we go wrong?
you got bitten with your own arrogance southern idiot. Suck on alim now.
Reversed my position in light of news regarding the physician utilization study.
- CEO's odd claim in conference call about the study being necessary for marketing but not approval. They are not two separate things. An FDA approval letter grants a company permission to market their product.
- The commercial syringe is different from the one used in the trial. Mannkind's commercial inhaler was different from the one used in their trial and they received a CRL. If the commercial device is different from the trial device, then you have to show equivalency. ALIM wouldn't spend $3.5M on a glorified ergonomic usage survey, they could do that without enrolling patients.
- All of the analysts were concerned about delays
so you reversed your position based on the physician utilization study, right!
Here is my two cents:
1) ALIM clearly stated that this study is not the condition of approval.
2) Since ALIM came to know about this in February, don't you think they would perform this study before the re submission in May if it is required for approval?
btw, it was the FDA that suggested to them that if there was any other population that was a pre determined population (at the start of the trial) and that had 3 years of statistical significance that they would look at it.
Number of years of having the condition was one of the pre determined population stats.
I get the point but what about the fact that DME seems to be a vascular problem at the onset responding well to lasar therapy... then moves more into an edema issue later which is why the ALIM device was so effective in comparison to standard of care for chronic patients.
Picking patients after 3 years doesn't sound like big mining project in terms of trying to find some data set that works for you. chronic...yes or no. If I had to guess, that's why the FDA said they would look at the data. ALIM did't go out of their way trying to engineer something that looked good.
I gotta disagree with you. I think they will give it due weight.