US Stem Cell Inc (USRM)

[Havoc23]

Additional information requests is common READ

From an FDA analysis

Since 2002 the number of Additional Information (AI) Letters per submission that the FDA sends to sponsors identifying questions they need to address – what are called “cycles” – has increased (see Chart 2). And, the percentage of submissions for which the FDA sends an AI Letter has also increased steadily since the start of the user fee program

Our analysis showed that, in the majority of cases, the FDA appropriately chose to send an AI Letter. These cases include, but are not limited to, circumstances where: (i) the sponsor did not submit required information without justification – such information includes supporting data required under current guidance or performance data that FDA consistently requires for certain device types; (ii) the sponsor failed to identify a predicate; or (iii) the sponsor employed different device descriptions or indications for use for the subject device throughout its submission.