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. Hope this helps.
:) ... I told you the answer was there. Just need to look closely at it. Do you know anyone scheduled for the injection? :) Have you talked with any optamologist? Hint Hint. Do your research and do it well, the answers are out there if you know where to look. Look closely at the past articles - who wrote them. Has anyone but me asked for names and phone numbers of the doctors? Anyone selling or shorting this stock is going to have a very red butt come Tuesday and Thursday of next week.
Yes it does help very much. My initial DD was greatly helped by going back thru the numerous threads that you and the other original Longs have compiled. I was able to confirm virtually all of the bullish points that you guys have made concerning PSDV. At times like this when there are many newbies, momo players and shorts muddying up the mb it's extremely helpful when true Longs present the Facts.
Kelly, Tom has owned a piece of this company for over 7 years. Tro' has owned it a bit longer. I'm a newb at 3 and change and will hold as long as it takes for biosilicon to get into the right hands. It will be a game changer. Tom is so right about the new limited label regarding the FDA decision. The data really does support it's passage and approval. The price fluctuation in this stock has always been puzzling, yet the CEO owns 5% of outstanding shares. The success of this company is his success. If you've done your DD as you say, you should be telling friends about the company. Ninety days from now will be a whole different deal, we long, longs promise you that. Good luck and thanks for bringing a little sanity to the boards.
Tom, Thanks for the clarity. This MB has lost it's mind. Hope you've found someway to pass the time until the FDA, I just want to shoot DDboy in the head. I'd explain it to the judge, and do believe I'd walk free because he'd would of liked to do it himself. But getting back to your point about chronic......you've cleared it up for a lot of people.