Ann: VivaGel BV granted QIDP and Fast Track designation by US FDA, page-47

well my dear friends, what a development this is. I didnt even know that such a thing as QIDP existed and wouldnt have thought Vivagel would get any kind of FDA designation! Quite a fortuitous turn of events indeed.

To answer the question regarding how long from submitting the NDA to getting approval? According to the FDA guidelines, Fast Track-ed products will receive a response 'within 60 calendar days of receipt of the request'. However, if the FDA is anything like the TGA, they can 'stop the clock' every now and again with shenanigans and questions and general bullshit. Good document that explains the designations:

http://www.fda.gov/downloads/Drugs/Guidances/UCM358301.pdf

We might actually get an answer from the FDA before the TGA even though the TGA application was put in in 2015!!!!! How bloody useless is that!? Doctors and patient bodies talking about antibiotic resistance and side effects that antibiotics cause (particularly on the gut flora), they got a perfectly good product that has NO SAFETY CONCERNS that has been stuck in the regulatory backlog for 2 bloody years! Disgraceful