new drug application

As pointed out by AVX earlier in the year, they were taking the interim results of the Phase III to a meeting with the FDA.

There are several stages in a drug's development where meetings are held with the FDA, such as before a Investigational New Drug application, end of Phase II, and the very important pre-NDA (New Drug Application) meeting.

Pre-NDA meetings with the FDA are generally held about 6 mths before filing a new drug application, and the meetings are held to discuss...

A pre-NDA meeting to discuss and achieve agreement on critical issues including:
• Whether preliminary evidence of effectiveness was seen in the principal controlled trials intended to provide evidence of effectiveness
• Structure, content, and timing of submission of the NDA
• Structure and content of any electronic submissions
• Structure, content, and timing of submission of portions of an application for marketing approval
• Readiness for, and proposed timing of, preapproval inspections
• Potential for, and proposed timing of, advisory committee presentation if applicable

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079736.pdf
http://ocw.jhsph.edu/courses/drugdevelopment/PDFs/IND-NDA%20Lecture.pdf

At a Pre-NDA meeting, it is also likely that the FDA provide guidance on when and what must be achieved by AVX before a NDA is submitted. So, for example, AVX may be required to take the successful first Phiii to 48 wks, or recruit 350 to the second Phiii, before filing.

Could the recent meeting between AVX and FDA be a pre-NDA meeting?

It certainly could be considering the stage of development of ATC, which may have completed its first Phiii, has Fast Track and Priority review, and is consistent with other recently approved HIV drugs which dont have the same efficacy against resistant virus, have more side effects, and aren't from such well known classes, such as the well known NRTI.

As Pre-NDA meetings are generally held about 6 months before filing, could we see an announcement soon from AVX advising of the outcomes of the pre-NDA meeting, and that a NDA from AVX will be filed early in the new year?

A recent hiv drug with accellerated approval and priority review was approved in 3.5 mths, and the FDA target is 6 mths.

So could we see ATC at market by mid next year, 2010!?!

What were those 'conservative' cash flow forecasts again, and the excessive discounting for the several years to get ATC to market???

The glass if not half full, it's overflowing!!!