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tagmonster

06/19/18 9:37 PM

#52310 RE: Parkmart #52308

Park, I believe we are waiting on the FDA's technical review to be completed upon the customer request. It may take 30 days or less (guess) and then we should know the first customer(s). This assumes APDN will make the name(s) public....

If an interested pharma gives APDN’s agent a LOA for approval and APDN approves, they give the LOA to FDA and access the info in the activated DMF.

Next Step Hayward:

" It will be reviewed by FDA for administrative conformance to their filing requirements at this time. It will be accessed by FDA for technical review upon a customer’s request to use the Applied DNA product within the customer’s pharmaceutic product."


If the pharma decides to use Colorcon/APDN marking, tracking and tracing, they update their own excipient DMF and reference Colorcon and APDN.

Cheers