Replies to post #52303 on Applied DNA Sciences Inc (APDN)

[tagmonster]

Hey Park, If your so inclined, would you please send Sanjay a follow up email asking for clarification. Will management publicize the names of the Pharma/Nutraceutical companies who are using the Colorcon/APDN Track and Trace solution once cleared by the FDA? If not, why not? Common sense tells us that companies using the T&T solution would want to market the fact that they are safe guarding their products and meeting/exceeding government regulations with new technology.

Thanks

[mcsharkey]

Yeah Park, on Sanjay's e-mail return to you and posted here on Friday, 05/25/18 03:16:50 PM, we all have some questions:

<Link to Post # 51978 of 52304>
Exactly what I asked Sanjay and here IE his reply:

“”The acknowledgement letter was received and, as is states in the link I provided to you last Friday, once a DMF is acknowledged, it is active. A DMF number has been assigned and will be made available via the same link I provided you once the FDA updates its DMF list. The FDA updates this list quarterly.”

YAHOO!!!!!!!!!!!

Ahh, only thing I can confirm is FDA acknowledged receipt on the DMF submission file. Not doubting Sanjay, however, we all been reading on DMFs for Type IV Excipient class. And, for reference

Excipient Master File Guide
<Link to White Paper posted by The International Pharmaceutical Excipients Council of the Americas>

A Type IV Excipient Drug Master File (DMF*) is a submission to FDA containing information that may be used to support an Investigational New Drug Application (IND), New Drug Application (NDA), Abbreviated New Drug Application (ANDA), Biological License Application (BLA), Veterinary Drug Application, another DMF, or an Export Application.

Seems like we just got started on this elaborate process.

Been Wrong Before,
VR
Mike Sharkey