RE:RE:RE:Corporate Overview January 16th1) Observer tells me that she is on the board but does not vote on any motions .
2) Reason for delay on filing ... this is my opinion on this ... it appears as though the world now has 2 approved treatments with the last one being in the limelight just a few weeks ago. All the talk and media coverage is all about getting rid of the plaque.. but the main stickler on this is that there is very little happening in stopping the progression of the disease in both cases. It has been mentioned by a few that showing that plaque is being removed , could have no bearing on what the drug is doing for the disease. I personally think that PMN has waited to see what the actual data was from the clinicals and they will make sure that in their filing they are addressing the short comings of these two other treatments. I am pretty sure that the FDA will be very pleased to see that PMN is not focusing on the plaque which has been the elephant in the room for the FDA who is being raked over the coals for approving these treatments. Just imagine a treatment that should have no brain bleeding and could show that it is slowing the progression of the disease. Game changer completely . Also If PMN can just apply the treatments with injections compared to intervenous or spinal taps ... another huge advantage. Remember what has been given to us for many years .. " we want to be BEST in class as compared to First in class.
Reference from PMN corp pres.
The Problem • Aβ oligomers are a major driver of Alzheimer’s disease but are much less abundant than other forms of Aβ (monomers, plaque) • Antibodies that bind monomers are directed away from the toxic oligomer target, reducing efficacy • Antibodies that bind plaque are associated with the risk of developing brain swelling (ARIA-E)
The PMN310 Solution • PMN310 selectively binds Aβ oligomers without binding monomers or plaque • Selectivity for toxic oligomers without monomer distraction expected to increase efficacy • Avoidance of plaque binding expected to reduce risk of ARIA-E
3. The last thing that I feel PMN has a distinct advantage over BIogen and what I believe will initiate the interest of large pharmas and the very strong possibility of a take over if we start to show good results .... Right now PMN has a distinct AD platform -- which includes Amyloid, TAU, and sitting in the back still being worked on " the AD vaccine" . Biogen right now appears to be a one horse trick pony in the AD field and depending fully on these limited treatments, and as others have mentioned .. they could just disappear once a better, cheaper treatment hits the floor. Compare ... how much has PMN spent on developing its treatment compared to Biogen and friends.
A few things to think about as PMN moves forward. Its very possible that PMN may have already submitted their IND to the FDA and we wont hear anything till they get the word to go ahead .