Replies to post #54633 on NorthWest Biotherapeutics Inc (NWBO)

[flipper44]

Hey Dok, the 'dream' you speak of -- 1st interim approval -- might wait 3 to 5 months after sufficient enrollment, like Tariquidar did (Just using it as a protocol example, not a result example), or wait for the second interim to allow time for the last enrolled patients to also have sufficient time for observation, to allow time for the secondary endpoint to draw nearer to completion before accelerated approval (FDA Guideline style), and to allow greater development of all subgroup statistics. It's impossible to say what is going on right now, but that is the "dream" scenario, IMHO.

[sentiment_stocks]

Regarding your question as to whether a company has to announce something like whether they've fully enrolled the trial, or whether they've reached an interim analysis point....

5) LP may not be required to announce that they are at the 1st interim review. This is where I am feeling unsure. I know people here know. Or did she actually say that they are not currently in an interim review? I don't think so. I think she said that before this hold. I know you guys know. - Dok

Such disclosure falls under the "Section 8 - Other Events" of the SEC General Instructions.

It is my opinion that the answer to that question is no.

They have the option to file such information under that section, but so long as they are not making this information known to anyone not under an NDA or in the employee of the company, they can choose to not disclose this information. Here are a few links that cover Section 8, as well as make clear what types of things do fall under the 4 day disclosure rules.

The registrant may, at its option, disclose under this Item 8.01 any events, with respect to which information is not otherwise called for by this form, that the registrant deems of importance to security holders. The registrant may, at its option, file a report under this Item 8.01 disclosing the nonpublic information required to be disclosed by Regulation FD (17 CFR 243.100 through 243.103).

https://www.sec.gov/about/forms/form8-k.pdf

and...

Section 8 ? Other Events Item 8.01 Other Events.
• The item used for optional disclosure of any event that the issuer deems of importance to security-holders not otherwise called for by another Form 8-K Item.
• Unlike most Form 8-K filings, there is no requirement that an Item 8.01 8-K be filed within four business days of the triggering event (see below for a further discussion of the relevant timing requirements).
• Commonly used for new product or other press releases and other miscellaneous non- categorizable events.
• An issuer will often use an Item 8.01 filing to update its shelf registration statement with more current information.

http://media.mofo.com/files/Uploads/Images/FAQ-Form-8-K.pdf

Still, for whatever reason, there are some that disagree with me on this... including Adam. You and others will have to come to your own final conclusions on that issue.