The next catalysts that investors are awaiting for, besides the 17th Oct. FDA's decision are:
- Italy's decision (they are the latest of the seven countries);
- the FAD for Iluvien in UK. ALIM was optimistic that a FAD would have been issued in September (so next week could be crucial), as stated in the 2Q's results PR.
Now, I know it might sound odd, but I personally believe that the result of the FAD could be key to the FDA's decision's too. If you look at NICE's documents, you will notice an in-depth analisys of cost-effectiveness on Iluvien, hence the decision to recommend for the subgroup patients. That is most likely one of the most important things the FDA is reviewing right now. Personally I am quite optimistic about this last attempt, as for chronic DME patients the results of the FAME studies were even better than the overall DME population and for this subgroup I don't think that other large studies could lead to significant new data to be added to what it's already known. However, if efficacy could be no deal to prove, cost is an issue and knowing how other Anglosaxon countries dealt with the problem in advance of the decision, could add some data to be taken into consideration.
Obviously just my personal opinion. Please make your own DD before investing.
No, there was no advisory panel for either of the FDA decisions. IMO if there had been one of retina surgeons they would have unanimously recommended approval as the IOP was all treatable and the cataracts are a non-event. The patients are going blind....this fact seemed to escape the grasp of the FDA.