Replies to post #375240 on NorthWest Biotherapeutics Inc (NWBO)

[biosectinvestor]

Hi MID. No, the clinical trial disclosure rules for that database have NOTHING to do with investors. It’s not an SEC or investor related rule. That is about sharing clinical data across the industry so that we can improve cancer treatments. It is intended to be good science policy. It has nothing to do with the scenarios about investments or other things that you posed. Broad hypotheticals could involve other rules or laws, but they have nothing to do with the NIH rules to encourage data sharing. It is good policy oriented, not about shareholder lawsuits or duties of loyalty or conflicts of interest.

[Poor Man -]

Boom, MI.

Not disclosing material negative information is playing with fire, subject to civil action and potentially criminal penalties. (There may be Sarbox implications as well.) Not revealing to the lender for the $11 million loan any negative information that would reach to the company’s capacity to repay that loan would be bank fraud under no uncertain terms.

I just can’t imagine that there would ever be a white enough gray area that LP and LG would really want to roll the dice.

How about if she were to strike financial deals like say an $11M loan with full knowledge of materially negative information that could easily bankrupt the company

[anders2211]

So you prefer bio s opinion over FDA text?
The point to all this is that thank goodness there is a good amount of pressure towards NWBO to at least provide trial results on or before July 22 202 thank God,

To which trials do the potential legal consequences described in 42 CFR 11.66 apply?

"Responsible parties" (as defined in 42 CFR 11.10(a)) must comply with the applicable provisions of section 402(j) of the Public Health Service Act (PHS Act) and the applicable regulations in 42 CFR part 11. The statute and regulations set forth the requirements for responsible parties to submit registration and summary results information to the ClinicalTrials.gov data bank for specified "applicable clinical trials" (ACTs) of drug products (including biological products) and device products.

ACTs are described in section 402(j)(1)(A) of the PHS Act and in 42 CFR 11.10(a). Any applicable clinical trial that (1) is initiated after September 27, 2007, or (2) was initiated on or before September 27, 2007, and was ongoing on December 26, 2007, must be registered with the ClinicalTrials.gov data bank (see section 402(j)(2)(C) of the PHS Act and 42 CFR 11.22(a)). For ACTs that are required to be registered, 42 CFR 11.42 describes for which trials results information must be submitted (see 81 FR 65121 for summary table) and whether they must submit the results information specified in sections 402(j)(3)(C) and 402(j)(3)(I) of the PHS Act or the results information specified in 42 CFR 11.48.

42 CFR 11.66 describes the potential legal consequences for responsible parties if they do not comply with the requirements to submit registration and results information on applicable clinical trials. Such potential legal consequences include civil or criminal judicial actions, civil monetary penalty actions, and grant funding actions.