Hat tip to PEDMAC2000

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biopearl123
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Joined: Fri Jul 20, 2018 5:13 pm

Hat tip to PEDMAC2000

Post by biopearl123 » Thu Sep 24, 2020 12:57 am

From YMB PEDMAC2000's response to a query of Geron:

"While the two seem inter-related, it’s really a matter of closing out a previous study in neuroblastoma, and ongoing dialogue with the European Medicines Agency’s Pediatric Committee (PDCO). As I am sure you are aware, both the EMA and the U.S. Food and Drug Administration require that a pediatric plan outlining a strategy for investigation of the new medicinal product in the pediatric population be agreed upon with each agency prior to submitting an application for marketing approval of a new drug. It is referred to as a pediatric investigation plan (PIP) for the EMA and a initial pediatric study plan (iPSP) for the FDA."

This related to updates noted by Fan on the clinical trials site regarding an old neuroblastoma ped study. Initial speculation was that maybe the updates were in preparation for a new neuroblastoma study. This does not appear to be the case but rather Geron's efforts to comply with regulations that must be met in properly closing out old studies, (in this case a pediatric study several years old), before a MA can be submitted. We just passed day 60 of the pediatric EMA committee consideration, with ongoing discussions with ongoing discussions to be held at the 90 and possible 120 day mark, as noted elsewhere. This is probably pro forma since there have been no pediatric heme studies of which I am aware. It seems that Geron is clearing the decks for an MA application. The question is of course when and whether it will wait until top line MDS or "first look" MF data or go forward as we hope on the basis of available data. One of the recent new hires is an expert in European drug approval processes. bp

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