Replies to post #362649 on NorthWest Biotherapeutics Inc (NWBO)

[Horseb4CarT]

I was a technical director responsible, among other things, software development of major systems.

Based on my experience, analysis of trial data is easier and faster to do than development of a new nontrivial application. You apply off the shelf statistical and mathematical code, which you use to implement the analyses called for in the requirements. In this case the requirements are the SAP, which was already defined and could have been used to prepare ahead of data lock.

Yes, there most likely customization to implement the specific relationships from the SAP, and review/change processes to iteratively finalize the final results.

However I can’t imagine a scenario where interim results have not been produced, and that the general TLD outlook hasn’t been discernible from the preliminary data.

I would guess the general assessment would have been available by January or prior, and more likely prior.

So I would factor that likelihood into the possible scenarios of what’s going on with the TLD delay.

[biosectinvestor]

Neither presumption is actually true. They do not have only 3 days to disclose under any rules and there are very few guidelines as to what is necessarily a bad result. Many companies like and do all kinds of data analysis and there is no requirement that they say something particular.

This kind of data is not covered by mandatory disclosure rules by SEC. Nor are they required to hold off on disclosure of good data for some predetermined amount of time. And the FDA rules relating to SHARING data are not really enforceable and have few consequences. They are not like SEC related disclosures and the FDA is also concerned with confidentiality, so they have not generally been approached as some sort of disclosure that requires FDA legal enforcement so far, not something that has bad consequences, at least as of my last review of these matters, not that long ago.

Companies have wide discretion. They can get themselves in trouble over time because they are required to give material updates via financials and other filings. So if they have important information that would be affected by other statements, an issue can become compounded without care. But disclosure rules are just not as cut and dried on trials as many on social media and some in the media suggest, often to imply things that are not subject to easy prediction just via implication and silence.