Bingo....................................... Ge
Post# of 30029
Posted On: 09/19/2014 9:01:14 PM
Bingo.......................................
Gerald is looking for an exit on LymPro. That is a fact, and for good measure - and for multiple reasons.
However, "exists" are entirely dependent on revenue recognition - and we have various "metrics" by which LymPro will generate revenue and seek reimbursements; all through the private medical industry, as well as the Federal Governments' Medicare/Medicaid insurance programs. This includes the ability to be able to successfully invoice via CPT codes here in the US - and obtaining the proper regulatory approvals to perform same - timely - and without lengthy delays.
We have steps ranging from RUO to LDT (CLIA) and onto full FDA commercialization - at different time frames - across different locations - US vs. International.
For us to get to the point of seriously considering a spin-off of LymPro or the Diagnostics Division, IMHO we would 1st have to be trading on the NASDAQ - as it is that milestone accomplishmnet alone which attracts the large institutional investors - and their financial muscle.
What will be the "financial engineering" items be that will propel us to a very small RS ratio - and what time frames are we measuring here - 4Q14, 1Q15, etc.
Here are 12 end of 4Q14 milestone targets quoted by GC in the latest blog that he believes will get us to uplist:
By the end of 2014 the Company anticipates:
01.) Announcing data from our ongoing LP-002 clinical study
02.) Completing the validation work at Icon to support LymPro’s launch
03.) Submission of the package to CLIA to support commercial launch as an LDT
04.) Announcing data for MANF in an undisclosed orphan indication at Targeting Ocular Disorders on October 6th, 2014, in Boston
05.) Filing an orphan drug designation application with the FDA for MANF in Retinitis Pigmentosa and immediately thereafter, we'll be submitting 2nd ocular orphan drug application for MANF with the FDA
06.) Initiating GMP manufacturing for MANF to support 1st-in-man clinical trials
07.) Additional data from ongoing MANF ocular studies
08.) Data from studies with Renishaw related to MANF’s Convection Enhanced Delivery use for Parkinson’s disease
09.) Submit request for Pre-IND meeting with the FDA for Eltoprazine next week
10.) Receive Feedback from the FDA on our proposed PD LID trial design (of note, based on a further analysis of the data, we expect the trial to be significantly less than 200 patients) and finalize the trial design
11.) Submit the IND to the FDA for Eltporazine
12.) Potentially have the 1st patient in potential Eltporazine trial for PD LID (due to the holidays this could end up being very early in 2015) in or around the JP Morgan Healthcare Conference
See more at:
http://www.thechairmansblog.com/amarantus-bio...cXBav.dpuf
Gerald is looking for an exit on LymPro. That is a fact, and for good measure - and for multiple reasons.
However, "exists" are entirely dependent on revenue recognition - and we have various "metrics" by which LymPro will generate revenue and seek reimbursements; all through the private medical industry, as well as the Federal Governments' Medicare/Medicaid insurance programs. This includes the ability to be able to successfully invoice via CPT codes here in the US - and obtaining the proper regulatory approvals to perform same - timely - and without lengthy delays.
We have steps ranging from RUO to LDT (CLIA) and onto full FDA commercialization - at different time frames - across different locations - US vs. International.
For us to get to the point of seriously considering a spin-off of LymPro or the Diagnostics Division, IMHO we would 1st have to be trading on the NASDAQ - as it is that milestone accomplishmnet alone which attracts the large institutional investors - and their financial muscle.
What will be the "financial engineering" items be that will propel us to a very small RS ratio - and what time frames are we measuring here - 4Q14, 1Q15, etc.
Here are 12 end of 4Q14 milestone targets quoted by GC in the latest blog that he believes will get us to uplist:
By the end of 2014 the Company anticipates:
01.) Announcing data from our ongoing LP-002 clinical study
02.) Completing the validation work at Icon to support LymPro’s launch
03.) Submission of the package to CLIA to support commercial launch as an LDT
04.) Announcing data for MANF in an undisclosed orphan indication at Targeting Ocular Disorders on October 6th, 2014, in Boston
05.) Filing an orphan drug designation application with the FDA for MANF in Retinitis Pigmentosa and immediately thereafter, we'll be submitting 2nd ocular orphan drug application for MANF with the FDA
06.) Initiating GMP manufacturing for MANF to support 1st-in-man clinical trials
07.) Additional data from ongoing MANF ocular studies
08.) Data from studies with Renishaw related to MANF’s Convection Enhanced Delivery use for Parkinson’s disease
09.) Submit request for Pre-IND meeting with the FDA for Eltoprazine next week
10.) Receive Feedback from the FDA on our proposed PD LID trial design (of note, based on a further analysis of the data, we expect the trial to be significantly less than 200 patients) and finalize the trial design
11.) Submit the IND to the FDA for Eltporazine
12.) Potentially have the 1st patient in potential Eltporazine trial for PD LID (due to the holidays this could end up being very early in 2015) in or around the JP Morgan Healthcare Conference
Quote:
"With that being said, we recognize that it is not optimal to up list from a position of weakness, and therefore we will only consider an up list from a position of strength while the Company is making good progress in the market. We believe the milestones we’ve outlined above – for the end of 2014 alone – will put us in that position. However, if we do not believe we have achieved sufficient shareholder value creation, we will consider delaying the up list until such time as the market recognizes our true value ."
See more at:
http://www.thechairmansblog.com/amarantus-bio...cXBav.dpuf
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