Posted On: 10/20/2014 10:50:01 PM
Post# of 30066
Milestones Company anticipates
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
Data from studies with Renishaw related to MANF’s Convection Enhanced Delivery use for Parkinson’s disease
And still on deck...
@ScottGlibowski Will be part of the updates to come shortly, including FDA update on Elto. On track with our stated plans
7:01am - 16 Oct 14
4 Milestones ahead for ELTOP - per 9.18.14 Blog
1) Submit request for Pre-IND meeting with the FDA for Eltoprazine next week
2) 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
3) Submit the IND to the FDA for Eltporazine
4) 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
http://www.thechairmansblog.com/amarantus-bio...WQ1OF.dpuf
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
Data from studies with Renishaw related to MANF’s Convection Enhanced Delivery use for Parkinson’s disease
And still on deck...
@ScottGlibowski Will be part of the updates to come shortly, including FDA update on Elto. On track with our stated plans
7:01am - 16 Oct 14
4 Milestones ahead for ELTOP - per 9.18.14 Blog
1) Submit request for Pre-IND meeting with the FDA for Eltoprazine next week
2) 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
3) Submit the IND to the FDA for Eltporazine
4) 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
http://www.thechairmansblog.com/amarantus-bio...WQ1OF.dpuf
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