NorthWest Biotherapeutics Inc (NWBO)

[IkeEsq]

actually, Happy was referring to § 11.42, clinical trial results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the Public Health Service Act (42 U.S.C. 282(j)(3)(C) and 42 U.S.C. 282(j)(3)(I)) or in § 11.48, as applicable.

42 U.S.C. 282(j)(3)(C) - Requirements for the Secretary of the NIH, for including data in the data bank for approved drugs and devices.

42 U.S.C. 282(j)(3)(I) - Requirements for the Secretary of the NIH, for determining "the best method for including in the registry and results data bank appropriate results information on serious adverse and frequent adverse events for applicable clinical trials described in subparagraph (C) in a manner and form that is useful and not misleading to patients, physicians, and scientists."

§ 11.42(a) applies to "Applicable clinical trials for which the studied product is approved, licensed, or cleared by FDA."

§ 11.42(b) applies to "Applicable clinical trials for which the studied product is not approved, licensed, or cleared by FDA. Unless a waiver of the requirement to submit clinical trial results information is granted in accordance with §?11.54"

§ 11.48 specifies what information is to be reported by ACTs in § 11.42.

§ 11.54 sets out the procedure for requesting a waiver of the reporting requirements. (Good for up to 2 years I think.)

So what you want to point to is § 11.42(b).

However, none of this gives individuals standing to enforce these requirements nor to force a government agency to prosecute a suspected offender. Once more, see e.g. Inmates of Attica Correctional Facility v Rockefeller, 477 F.2d 375 (1973).

What HappyLibrarian suggests is that like seeking some TRO or injunctive relief, one can walk into Federal court, make a statement that somehow requires the judge to hold a quick hearing and then the Court will issue a Writ requiring the FDA to enforce a law on a specific company, that the FDA will then immediately order the company to release TLD and the company will then, a week after the motion was filed, release TLD. What I am telling you is that it WILL. NEVER. HAPPEN. You have no standing. You can point to no harm. The FDA has no obligation to prosecute specific companies that you wish to hold accountable, especially when less than half of trials have results reported on time. The Judge is going to defer to the Agency absent some flagrant abuse of discretion. "Arbitrary and Capricious" is the term you will likely see.

If the Judge doesn't simply dismiss the case out of hand, it gets sent to the appropriate government agency for a response. Expect a response in 3 months or so. The response will likely request dismissal under 12(b)(5) or require an amended complaint stating the particulars. Another 4-6 months may pass before the motion to dismiss is considered and a year or so after filing your case is dismissed for lack of standing or failure to state a claim.