As you are aware, we are in the FDA submission process for our first drug. We wanted to share this exciting news with you since what occurred is a rare event, even for large pharmaceutical companies.
Dawah's team members specializing in FDA submissions have been in correspondence with the FDA. Before submitting our application, we had three questions for the FDA to answer to prevent any delays. Within 5 days of submitting these questions, the FDA Scientific Officer called our team to discuss the answers to our questions.
They stated only one question needs to be answered and that the other two will logically follow, which is in our favor. It is very unusual for the FDA to call anyone since they always correspond in writing. This means that they are trying to move faster internally on their end, and we were assured by the FDA Scientific Officer that the FDA decision on our questions will be delivered in 60 days or less.
This news should be treated with great excitement, and we are confident we will have a speedy turn-around time with the approval, thereby meeting our production schedule and begin to generate revenue at a faster pace than we originally expected.
More to follow.
Dawah Pharmaceuticals Inc.
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