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wsbc

01/17/19 3:53 PM

#254323 RE: KMBJN #254319

Agreed. I'm sort of feeling like the trial organization and execution is a byproduct of general lack of sufficient economic backing. (which isn't an explanation of strange reporting or analysis)

I also am not quite understanding why targeting a specific partner who's articulated an interest, with specific interim desired-data, hasn't been happening.

SO much going on that makes zero sense to me related to how they're 'running this as a business'.

Goofy how they report median duration of SOM on the entire population of 21 subjects that received brilacidin, instead of just the 9 who got SOM. The duration of SOM for the 12 subjects who didn't get SOM was obviously 0, so the 0 statistic of median SOM duration across the brilacidin population is meaningless / not at all descriptive of the duration of SOM for those who actually received brilacidin and had SOM.

Likewise for the placebo group - why not report the median duration for only those who got SOM, not the entire group (which includes those who didn't get SOM)?

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scottsmith

01/17/19 5:12 PM

#254331 RE: KMBJN #254319

Rhetorical question?

“Likewise for the placebo group - why not report the median duration for only those who got SOM, not the entire group (which includes those who didn't get SOM)?”

Goofy you say?
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frrol

01/17/19 9:53 PM

#254344 RE: KMBJN #254319

Yes and it can be misleading for inexperienced investors. The potential BP partner of course got all the data and doesn't rely on PRs or the clinical trial .org website.

But experienced investors here like you can inform the board about what the data really shows and keep things objective and realistic. You're correct that there are some chicken feathers in our soup, and that the company presents findings in an potentially misleading light. It should be pointed out though that Galera did the same thing with median days. Small biotech can be aggressive with public announcements.

A few things are comforting. While one of the 'feathers' is that the failed arm had an unusually high placebo result, this muted the possible efficacy signal in that arm (since the endpoint was comparative). Of course this raises questions of its own, but the BP is aware of all of this and still agreed to a term sheet. Another issue is our small OM trial sample size, but it is comforting that B demonstrated possible anti inflammatory effect in the P2A IBD trial. In fact the term sheet included OM and IBD. So there's more empirical backing to B's effectiveness than just that small OM trial. The BP is no doubt considering both trials when assessing whether B is potentially effective as an AIF platform.

So we wait to hear something. This is no slam dunk but I think we're still in the game.
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PlentyParanoid

01/18/19 10:53 AM

#254355 RE: KMBJN #254319

I agree with you that reporting only median is very uninformative in this case. But it is the traditional pharma way how 'time to event' measures are reported. As far as I know all clinical trial reports concerning oral mucositis give median duration for SOM and not much more.