@Bazsa, The entire issue of "no trials until CMC issues are resolved is unclear to me as an investor"... The company has an IND authorization from the FDA to conduct trials. That same authorization is used to give product to patients in an EAP. So, was the EAP program for children stopped?? Was a formal suspension of the IND issued by FDA or did they just give the company a recommendation as to the best way to proceed forward ? Not clear...but normally "IND on hold" would be a reportable event generating a separate PR. Regarding your last sentence, it's also not clear what "results" we're talking about.
CEO Itescu needs to go, page-608
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