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Re: erik007tc post# 683800

Sunday, 04/07/2024 10:54:16 AM

Sunday, April 07, 2024 10:54:16 AM

Post# of 822880
There is virtually a 100% chance of an RFI.. If you read the 10K in LPs own words, you'll see that.
The real question is.... Did they accept the application yet and when will the RFI and acceptance be announced?... From the recent 10K, PS where is the ASM?

"For the GBM MAA, the Company anticipates that the review process will be a period of intensive and extensive further work involving responding to questions and requests for further information by the regulatory authority as well as preparing for and undergoing detailed inspections of the contract research organizations (CROs) that managed the trial, the Sponsor, the Trial Master File, a number of individual trial sites selected by the regulator from among the 94 sites that participated in the trial, the GMP facility and manufacturing information."
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