The Office of Compliance and Biologics Quality (OCBQ) in the Food and Drug Administration's (FDA's) Center for Biologics Evaluation and Research (CBER) has reviewed a Product Fact Sheet entitled “SparVax™ – Recombinant Protective Antigen (rPA) Anthrax Vaccine-Novel Second Generation Vaccine Technology” for your investigational product Bacillus anthracis Recombinant Protective Antigen 102 (rPA; E. Coli) (anthrax) vaccine -b(4)---. The product fact sheet contains false or misleading statements that represent your product as safe and effective for the purposes for which it is being investigated. This is problematic from a public health perspective because it suggests that SparVax is safe and effective when the product has not yet been approved by FDA and the promotional claims have yet to be demonstrated by substantial evidence or substantial clinical experience. As a result, these materials misbrand your investigational product in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a)&(n), and 321(n), and FDA’s implementing regulations. (See 21 CFR 312.7(a)).Because the violations described above are serious, we further request that your submission include a plan of action to disseminate truthful, non-misleading, and complete information to the audience(s) that received the violative material.
As you can plainly see, Pip has a history of disseminating misleading and non-truthful information. Just like when they put non-binding on the lats with Siga or stalled to get a peek at the test results, or pulled out of the merger so they could steal a license? Lucky for Pip they either bought a judge or found some truly blind justice.
The issue raised in this letter pertains more to marketing/description of an investigational product without making it clear that it is being tested/developed for this purpose and not yet approved. Such marketing issues are often raised by office of prescription drugs and other divisions within the FDA dozens of times each year. Google "FDA warning letters 2013" for links to examples thus far this year.
While we are at it, lets stick to the facts: 1) They (and SIGA) including a LATS, which was labled 'non-binding', into binding agreements. 2) PIP could not raise the money even after the results from animal study for ST-246 was available, so there was no benefit derived by PIP even if it were true they had slowed the process of completing the financing needed to consummate the merger 3) It was SIGA that executed its right to terminate the merger not the other way around. The issue of the license did not arise until SIGA, as two courts have now determined, acted in BAD FAITH in violation of binding agreements to negotiate a license in good faith in accordance with the terms of the LATS. The only firm trying to lie, cheat and steal, as supported and documented in court proceedings was SIGA.