By the end of 2014 AMBS anticipates:
Announcing data from our ongoing LP-002 clinical study
Completing the validation work at Icon to support LymPro’s launch
Submission of the package to CLIA to support commercial launch as an LDT
Announcing data for MANF in an undisclosed orphan indication at Targeting Ocular Disorders on October 6th, 2014 in Boston
Filing an orphan drug designation application with the FDA for MANF in Retinitis Pigmentosa and immediately thereafter will be submitting a second ocular orphan drug application for MANF with the FDA
Initiating GMP manufacturing for MANF to support first-in-man clinical trials
Additional data from ongoing MANF ocular studies
Data from studies with Renishaw related to MANF’s Convection Enhanced Delivery use for Parkinson’s disease
Submit request for Pre-IND meeting with the FDA for Eltoprazine next week
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
Submit the IND to the FDA for Eltporazine
Potentially have the first 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...CLTEq.dpuf
Announcing data from our ongoing LP-002 clinical study
Completing the validation work at Icon to support LymPro’s launch
Submission of the package to CLIA to support commercial launch as an LDT
Announcing data for MANF in an undisclosed orphan indication at Targeting Ocular Disorders on October 6th, 2014 in Boston
Filing an orphan drug designation application with the FDA for MANF in Retinitis Pigmentosa and immediately thereafter will be submitting a second ocular orphan drug application for MANF with the FDA
Initiating GMP manufacturing for MANF to support first-in-man clinical trials
Additional data from ongoing MANF ocular studies
Data from studies with Renishaw related to MANF’s Convection Enhanced Delivery use for Parkinson’s disease
Submit request for Pre-IND meeting with the FDA for Eltoprazine next week
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
Submit the IND to the FDA for Eltporazine
Potentially have the first 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...CLTEq.dpuf
