NorthWest Biotherapeutics Inc (NWBO)

[Pyrrhonian]

Hey fox, here's what I've come up with: there are not only two possible abstract categories, TIP or LBA. Those are the only two given a special category. The rest are non-LBA/TIP abstracts.

The Direct trial cannot be included as a LBA because, as you pointed out, that category requires it be a randomized trial set to release information at this particular junction. Secondly and quite succinctly, they state:

"Each first author will receive a letter of notification via email from the Committee regarding its decision on the abstract in late March. Each first author of a Late-Breaking Abstract will receive a letter of notification regarding the final decision in mid-April."

And we obviously received confirmation in late March.

Now, I also don't think it will be a TIP. We have this issue:

"Trials submitted to this session are ongoing and have not reached prespecified endpoints for analysis. As such, inclusion of results would be improper and is strictly forbidden."

This, interestingly, does not fit with the DCVax Direct trial, even if we consider it in its Ph I stage, for "dose finding, tolerability and safety," only. There would certainly be data on these, as well as "an eye for efficacy," as according to the CEO. Likewise there are no "prespecified endpoints for analysis," like we have with DCVax L.

Also it says "Enrollment must have already begun or have been completed with no data analysis available." Again, this seems to refer to a blinded trial.

This then negates them from being in the session you opined they would be, namely the General Poster Sessions. They may be in two of the other three, however, all of which convey up-to-date (as of May 19th) data findings. I am of the opinion, and given the presence of Vivek Subbiah, that they will be presenting in the Oral Abstract Sessions as opposed to the Poster Discussion Sessions (though it very well could be the latter). However, it won't be the Clinical Science Symposia, as the DCVax Direct trial would not qualify as "meritorious."

Now, as far as what may be said during the conference as opposed to what is stated in the abstract:

"For a study to be eligible for acceptance into the ASCO Annual Meeting, information contained in the abstract, as well as additional data and information to be presented about the study at the ASCO Annual Meeting, must not be disclosed before the findings have been publicly released in conjunction with the ASCO Annual Meeting."

Also a reason why, whenever they decided to go for ASCO, management had to go mum on seen developing results. However, it seems clear they have "additional data and information" not part of the abstract that will be released and discussed at the meeting itself, during these "sessions."

Another mention of this, which states that public release (by webcast/ newswire) of the information happens at the same time these sessions are given, goes:

"If information from the abstract or additional study data are disclosed in advance of public release in conjunction with the ASCO Annual Meeting, the abstract will be subject to rejection, removal, or downgrade, unless an official Confidentiality Policy Exception applies."

So then, it would not be "inside information" to discuss what is not in the abstract during a session, or later at their booths. The findings will be made public (outside of ASCO) concurrently, either by live streaming or newswire.

Thanks for prodding me to dig deeper. I don't think we will find out exactly what session they will be in on the 21st (abstract title release date), but it may give us some clues. We may have to wait until May 14th, or even the conference itself to know for sure.