After what I would call a couple of lackluster wee
Post# of 30028
Posted On: 12/19/2014 1:34:51 AM
After what I would call a couple of lackluster weeks it felt good to go back and reread literature on Lympro. I don't recall the specifics or even if AMBS would risk pissing off the FDA or EMA maybe someone else can answer this question more clearly.
Going back through the PR's, Chairman's Blog, Zacks, JN's writings etc. I'm wondering if we don't already have an already full booking from around the globe to be processed in the RUO's? Makes sense to me since Gerald stated he has been working on it for months and months. And more to the point does the RUO the FDA requires from where we're at have any weight with regards to us just saying "OK FDA we'll jump through your hoops here within your borders but elsewhere, Ireland, Singapore, China and India where ICON has CLIA's already set up maybe they are more lax and willing to allow public testing before everything is FDA or EMA approved.
Even if this doesn't fit into the mix because it could be to risky to piss off both the FDA and MEA there are currently an estimated 14,500 individuals currently in Phase 2 clinical studies in the U.S. for Alzheimer’s disease. Lets say they started with 2X that plus add in a test after the trials maybe once during of either version 1 or 2 of Lympro. How many trials do you think are happening in India and China? It's not like they have the strictest laws when it comes to manufacturing prescription drugs or anything.
I feel a lot better now and wanted to share some food for thought if you were a little down and needed a boost.
BOL
I love this interview David Lowe did. It really hammers home the ESS transaction and possible pathways to financing other than dilution.
http://www.24hgold.com/english/contributor.as...ces+Report
Other links where I got information:
http://scr.zacks.com/News/Press-Releases/Pres...fault.aspx
http://globenewswire.com/news-release/2014/10...est-R.html
http://www.thechairmansblog.com/amarantus-bio...-progress/
http://www.bizjournals.com/prnewswire/press_r...14/NE29909
Going back through the PR's, Chairman's Blog, Zacks, JN's writings etc. I'm wondering if we don't already have an already full booking from around the globe to be processed in the RUO's? Makes sense to me since Gerald stated he has been working on it for months and months. And more to the point does the RUO the FDA requires from where we're at have any weight with regards to us just saying "OK FDA we'll jump through your hoops here within your borders but elsewhere, Ireland, Singapore, China and India where ICON has CLIA's already set up maybe they are more lax and willing to allow public testing before everything is FDA or EMA approved.
Even if this doesn't fit into the mix because it could be to risky to piss off both the FDA and MEA there are currently an estimated 14,500 individuals currently in Phase 2 clinical studies in the U.S. for Alzheimer’s disease. Lets say they started with 2X that plus add in a test after the trials maybe once during of either version 1 or 2 of Lympro. How many trials do you think are happening in India and China? It's not like they have the strictest laws when it comes to manufacturing prescription drugs or anything.
I feel a lot better now and wanted to share some food for thought if you were a little down and needed a boost.
BOL
I love this interview David Lowe did. It really hammers home the ESS transaction and possible pathways to financing other than dilution.
http://www.24hgold.com/english/contributor.as...ces+Report
Other links where I got information:
http://scr.zacks.com/News/Press-Releases/Pres...fault.aspx
http://globenewswire.com/news-release/2014/10...est-R.html
http://www.thechairmansblog.com/amarantus-bio...-progress/
http://www.bizjournals.com/prnewswire/press_r...14/NE29909
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