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Monday, June 27, 2016 9:02:32 PM
Anyhow, all you need to do is read about Section 8. Other.
https://en.wikipedia.org/wiki/Form_8-K
They can fully submit a BLA without releasing information to us. There are all sorts of material information that they can keep from the public. It's fully in the company's control to decide to release or not release such information.
Would you say the reason for the halt is material? Have they released the reason? No.
And that's because they don't have to.
So long as they keep the material information nice and tidily locked up, they needn't say a thing about it.
With the exception of certain pre-specified events like changes in or with directors, senior officers, delisting notices, accountants, and SEC filings, they don't have to PR it.
In fact, the aforementioned screening halt is a perfect example.
When did they know about the screening halt? If they knew about it earlier than when tasty found it, did they PR it? No. They didn't have to until the knowledge of it became public. You helped a bit with that with your tweet.
And so with regards to AA or priority reviews... I've not found one example of a company that's PR'd they are filing for either such designation. They may hint they intend to... as did Celldex on the Rindo P2... but they'll NEVER PR they filed for it. In fact, you'll find no such example of a public PR of that even for Celldex.
Now... a company may announce they are filing for a BLA... but never in conjunction with a priority review. Usually a company will file for a BLA after the data has been made available or the company has announced they have it and intend or are filing. But even that doesn't happen all the time.
So, if a company were still running a trial, and it was still blinded, and they were being shorted magnificently, and they made the news every other week as if they were the most newsworthy biotech company on the planet (well maybe they are)... the company might think twice about what information they make public. For instance, regarding the combo trials. Don't you think it might be better to PR that your first patient has been treated in a combo trial, rather than announce your intent to treat patients in a combo trial? If you don't think that, I can assure you, I do. If they announced they'd filed for this or that... you'd simply write some blather about how they'd never get it. It kind of loses it's punch. Better to keep you on your toes... wondering whether you will get to publish your book, or not? It won't be terribly interesting if NWBO is successful, now will it?
If the reason for the halt were made public - like Linda explained it during some event, she'd have to PR it. If she shares a material event with the public in some manner, then she has to share it with everybody.
So you posting boldly on here stating they didn't submit a BLA doesn't make it so Adam. You can stamp your feet, and jump up and down, and loudly shout that they didn't file this or that ... but they are simply just words. Writing them doesn't make them true. And I understand, the same applies to what I write. But I do try to support my theories with actual statements from such places as the FDA site.
:)
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