From: "Gabe Fernandez MD" Date: Thu Oct 2, 2003 11:22 pm Subject: Last 12 months MY INTERPRETATIO
I remember before when the FDA requested further data from Pharmos before approving the IND. There was a substantial delay until Pharmos presented added studies which included testing in simians. Tbird, office boy Cheoff,brkmark the priapists and other Phenoms volunteered. My eternal thanks to them and their masters since it permitted us to buy the stock at bargain prices.
Pharmos performed well,submitted the data and the IND was finally approved several months ago. The studioes in the USA which were predicted by our Bashers Phenoms would never occur. They were wrong. We have 15 centers going. Pharmos also stated at the last meeting that we qualified for Fast Track and Orphan Drug status. Pharmos requested the Fast Track and it was granted by the FDA. The next logical news will be the granting of Orphan Drug status. Granted that both do not gurantee the approval or good results of the science of Dexanabinol but it also establishes an important point. The FDA request and we comply and apparently they approve of our cooperation. The FDA is aware of the significance of Dexanabinol as the only Neuroprotectant available in the near future. In essence they are aware of the need of such a product.
We hear that the FDA acts in mysterious ways at times but we also read that the attitude of the FDA is more relaxed and cooperative in establishing new drugs. Pharmos by its submission of data requested by the FDA in a positive manner should have made the FDA aware of Pharmos due diligence and Dexanabinol's need not only in TBI but in the Neuroprotectant arena.
The question is when will Big Pharma and the investment Biotech analyst arena realize that indeed there may be something to this small company. The need of new products by Big Pharma is real,as we see reported.
The catalysts for our company will occur in sequence: 1- Approval of Orphan drug status this Q. 2- Completion of enrollment for Phase III TBI in early 2004 or as I believe and hope this year. 3- Report on Phase IIa MCI-CABG Dex trials and as I believe a succesful trial. Expected time table for this event 1st Q 2004 This last event is the one that will finally alert the Big Pharma giants that indeed Pharmos would be a good marriage partner. The possibility of having a drug with these many disease entity indications is so large that it would be in their best interest to have a piece of the action. It is PROBABLE that Aviv will still want to wait for the submission of the NDA for TBI. I hope that it occurs sooner but eventually our long wait will be rewarded. 4- Report on TBI results which either way could be a bombshell.I firmly believe in the positive aspects of the same. 5- Submission of NDA. 6- Approval of same by regulatory agencies. Believe Israel should be the first.
My Parsians friends I have been attacked as a cheer leader and crony of Pharmos. I many years ago mentioned my belief that Dexanabinol, if effective, would be a drug that would prevent or at least modify the POST INSULT CASCADE. This insult been of traumatic,inflamatory,infectious,degenerative cause etc of any ORGAN not only BRAIN. Can you imagine not only the significance of reducing the area of ischemia in a stroke,think also about reducing the area of infarct in a heart attack. Some Bashers even admit that at best we are a 5-10 dollar company. That is fine if our point of entry is now. gl gabe
All said with whoafully little data to back it up it true effectiveness. Thats their biggest problem, they just don't have enough data to prove anything at this point. P2 barely showed more than statistical chance of anything positive. Thats why the price is low, not because this type of product is not need or anything else. Just pointing out the facts in case anyone thinks this is a slam dunk.
reallynollie: Your point that: "All said with whoafully little data to back it up it true effectiveness."
Point is correct the science of Dex has not been proven as we speak but there are many clues that point to the probabillity of success. In essence, it is like a legal case, we have a great deal of circumstantial evidence that point towards the main point NEUROPROTECTION 1- Phase II TBI results 2-Fact that we are in Phase III with no safety issues. 3-Why start a new study CABG-MCI unless there was confidence in success. The money of Pharmos is indeed tight. 4-The multitude of increase research in Cannabinoids in other fields Pain,anti angiogenesis etc 5-Granting of Fast track even though it does not in itself affect approval does indeed confirm need of product. 6-Comments from leading Neurosurgical TBI experts. 7-Endorsement of Phase III by EBIC-ABIC 8-Participation of EBIC-ABIC in the protocol development. An area responsible for previous TBI failures. 9- Nature of protocol and its strictness which assures that those accepted are those most likely to suffer from ICP problems and Neurological deterioration. Both points of major importance in TBI as Phase II showed. 10- Finally reports and analysis of Dexanabinol by other trauma and neuroanesthesia leaders.
The clues of success are there and it can be purchased at 2.60/share. gl gabe
>>> All said with whoafully little data to back it up it true effectiveness. Thats their biggest problem, they just don't have enough data to prove anything at this point. P2 barely showed more than statistical chance of anything positive. Thats why the price is low, not because this type of product is not need or anything else. Just pointing out the facts in case anyone thinks this is a slam dunk. <<<
That's bullshit, just pure bullshit. Stat sig numbers were obtained, thru ALL three cohorts in ICP control, CPP numbers and hypotensive episodes. THAT are the facts. Be so kind to note the sources of your 'facts'... I'll respond in kind. Let's hear it...