To say that previous failure ensures future failure is pure nonsense. The ACAD story isn't a perfect comparison to PSDV but it's reasonable. Lessons learned from previous trial errors can greatly increase the chances of approval on the 2nd or 3rd attempt. That is exactly why I originally bought ACAD last Nov.
Sentiment: Strong Buy
Too many of you folks on this message board don't get it on the difference between the current FDA submission and the previous two submissions. They are very different! The current submission is asking for approval for CHRONIC DIABETIC MACULAR EDEMA not standard Diabetic macular edema. The difference is huge, in that CDME side effects/risk benefit ratio is believed to be in the acceptable range. This was borne out in the previous trials thus eliminating the need for additional data. The risk/reward is the key to success. The prime consideration in rejection of ILuvien for DME was the treatment to patients with mild DME could result in the formation of cataracts to treated eyes, however many of the patients with CDME eyes already have cataracts thus creating an acceptable level of risk versus reward and this indication if approved will also be approved on the basis of the patient must have or have had cataracts on treated eyes.
godwintom gets it!!!
Alimera submitted the chronic data on their last rejected submission to the FDA. The FDA could have given them a chronic label in 2011 but bureaucratic central planning commissars and apparatchiks operating the FDA under the Obama administration refused on the grounds that somehow IOP treated with drops or cataracts represent a crisis for someone going blind.