BioSante Pharmaceuticals, Inc. (BPAX)

[Just the facts maam]

This is for those still in doubt about Libigel's viability. For the unmet need of HSDD, the following should be a compelling argument to not only approve Libigel for it's intended purpose, but also allow for an expanded use regarding the CV benefit.

New Drug Application (NDA)

Introduction
For decades, the regulation and control of new drugs in the United States has been based on the New Drug Application (NDA). Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

The goals of the NDA are to provide enough information to permit FDA reviewer to reach the following key decisions:

1 - Whether the drug is safe and effective in its proposed use(s), and whether the benefits of the drug outweigh the risks.

The Bloom trials Libigel equaled but did not beat placebo in the increase sexually satisfying events (a subjective result) but Libigel beat them hands down in restoring testosterone to pre-menopausal levels (an objective result)

The safety trails proved the 70% reduction in cardiovascular events which is now supported by two patent applications, the placebo provided no benefit.

In my books that is 2 wins & 1 tie for Libigel vs 2 losses & 1 tie for placebo.
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2- Whether the drug's proposed labeling (package insert) is appropriate, and what it should contain.

To be determined


3 - Whether the methods used in manufacturing the drug and the controls used to maintain the drug's quality are adequate to preserve the drug's identity, strength, quality, and purity.

This is addressed by the most recent patent application on mass production.

The documentation required in an NDA is supposed to tell the drug's whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body, and how it is manufactured, processed and packaged. The following resources provide summaries on NDA content, format, and classification, plus the NDA review process:

This allows the use of the Phase 2 trial in the application which Libigel did very well in efficacy and the placebo acted more in line with other placebo's

NDA GUIDELINE FOR APPLICATION

Section F allows for the presentation of other studies (i.e, Intrinsa)

F. Other Studies and Information [21 CFR 314.50 (d)(5) (iv)] 25
1. Overview 25
2. Format/content 25
a. Table of all studies and other information
b. Reports of individual studies - order of presentation
c. Reports of controlled or uncontrolled study of uses
not claimed in the application
1) Synopsis
2) Protocol, CRF, amendments
3) Publication
4) List of study participants/compliance with parts 503 56
5) Report of study
d. Reports of commercial marketing experience
e. Overall summary