MSB $1 Party, page-780

The FDA are overwhelmed so finding ways to stall applicants is their business now( read below ) ... What's it mean for us ...Well I'm not sure FDA are fans of cells
So are they going to keep up the stalling tactics as per below. I cant see anything being done on expected timetables at the FDA which is going to hurt MSB a lot


Another refuse-to-file for a small biotech — is the FDA using RTFs to manage its workload?Zachary BrennanSenior EditorAs the regular flow of NDA and BLA submissions continues to pick up, it’s little wonder that an already Covid-beleaguered FDA seems to be increasingly turning to refuse-to-file letters as a means to provide instructive feedback, and perhaps even to slow the pace of its workload.The latest RTF letter, disclosed Thursday by Aeglea BioTherapeutics, a penny-stock, clinical-stage biotech company calls for new efficacy data to be included in its BLA for pegzilarginase for the treatment of the rare, progressive and debilitating disease characterized by high levels of arginine, and known as Arginase 1 Deficiency. The company’s stock price fell by more than 40% on Thursday.Unlike complete response letters, which are essentially FDA rejections, RTFs allow the FDA to reject an application before beginning a more complete review. But some tracking the industry closely think the FDA has been turning more and more to these RTFs, and in instances where the agency may have seemed to be less than forthcoming, or so the companies say.