It will be 60 days before this FDA Regulatory "dra
Post# of 30028
Posted On: 08/03/2014 9:16:14 AM
It will be 60 days before this FDA Regulatory "draft" is published which will only begin public debate and comment. I don't think FDA regulation would begin, if it ever does, for quite some time after the 60 days. Congress will also have to weigh in on it. I think LymPro will already be commercialized before any proposed regulation would begin.
The U.S. Government is spending so much money on Alzheimer's Disease through medicare already, and with the baby boomers entering their 70's soon, the cost is only going to skyrocket. LymPro will most likely already be in use by most Pharmas doing AD clinical trials before this proposed regulation ever takes effect. I doubt very much whether the FDA is going to stop these Pharmas from using Lympro if they say it is helping them find a cure for AD. If anything, if regulation comes in a year or two it might effect our future competitors who are a couple years behind us, more than it will effect us.
Plus, a year from now LymPro will have tested so many people under CLIA that they will be knocking at the FDA's door for out right FDA approval!! And I think Big Pharma doing AD clinical trials will be putting pressure on the FDA to do it. The sooner LymPro gains FDA approval and reimbursement the sooner the cost will go down from $1,500 to $1,000 and then down to $500. That will make it less expensive for Big Pharma to find AD cures.
So while anything is possible, I think it is very unlikely that this proposal will materialize soon enough to derail LymPro's launch or effect it's 2015 & 2016 CLIA revenue.
The bashers and flippers are out in full force using everything they can think of to cast a cloud of doubt over LymPro. I'm not buying it. The data presented Thursday was fantastic! AMBS will learn to communicate to non-scientists in the very near future. They've learned their lesson about speaking over their shareholder's heads. But there is nothing wrong with Lympro and it is on track to commercialize by November or December.
The U.S. Government is spending so much money on Alzheimer's Disease through medicare already, and with the baby boomers entering their 70's soon, the cost is only going to skyrocket. LymPro will most likely already be in use by most Pharmas doing AD clinical trials before this proposed regulation ever takes effect. I doubt very much whether the FDA is going to stop these Pharmas from using Lympro if they say it is helping them find a cure for AD. If anything, if regulation comes in a year or two it might effect our future competitors who are a couple years behind us, more than it will effect us.
Plus, a year from now LymPro will have tested so many people under CLIA that they will be knocking at the FDA's door for out right FDA approval!! And I think Big Pharma doing AD clinical trials will be putting pressure on the FDA to do it. The sooner LymPro gains FDA approval and reimbursement the sooner the cost will go down from $1,500 to $1,000 and then down to $500. That will make it less expensive for Big Pharma to find AD cures.
So while anything is possible, I think it is very unlikely that this proposal will materialize soon enough to derail LymPro's launch or effect it's 2015 & 2016 CLIA revenue.
The bashers and flippers are out in full force using everything they can think of to cast a cloud of doubt over LymPro. I'm not buying it. The data presented Thursday was fantastic! AMBS will learn to communicate to non-scientists in the very near future. They've learned their lesson about speaking over their shareholder's heads. But there is nothing wrong with Lympro and it is on track to commercialize by November or December.
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