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Message: Re: My guess is a second BTD is coming

I think we may hear something regarding a second BTD regarding cognitive decline before CKD. 

Reading the transcript of DM's post-CTAD CC, he states the following on Slide 13:

"Then of course today’s announcement, the cognitive function improvement of 158% in the MoCA below 22 group with a p value of 0.02. Now I mentioned earlier it may be called an accidental breakthrough, but we now have a solid basis to explore cognitive function as a stand-alone or a synergistic drug. And it’s very exciting data. This field in cognitive function does not see results like this. Very very thin results usually occur in trials in this particular category, so clearly I think we’ve done some major breakthrough work here."

Link to imtesty's transcription here: https://agoracom.com/ir/Resverlogix/forums/discussion/topics/734489-betonmace-prespecified-cognition-assessment-results-post-ctad-conference-call-transcript-191206 

DM specifically mentions 'breakthrough' twice in that paragraph, and I don't think that was a coincidence.

Here is a link to an article on alz forum where they discuss RVX's CTAD presentation: https://www.alzforum.org/news/conference-coverage/going-indirect-can-therapies-halt-alzheimers-outside-brain

Of note from that article is the following:

"Based on these results in people with cardiovascular disease, as well as apabetalone’s effects on markers of vascular inflammation, Cummings believes the drug assuages cognitive impairment by targeting the inflamed vasculature. Whether it is more effective at treating people with vascular dementia or AD remains to be determined. BETonMACE was not designed as an AD trial, so the researchers did not measure AD biomarkers. However, given recent advances in plasma biomarker tests, Cummings told the audience that existing plasma samples from the participants will be tested for Aβ42/40 ratio, p-tau-181, neurofilament light (NfL), YKL-40, and other markers." 

Full disclosure: I'm not a doctor or specialist in the dementia/alzheimer field, nor do I play one on TV, so my knowledge regarding what biomarker information these plasma samples would provide to RVX is extremely limited. Other people on this board can probably expand more on the relevance of specific biomarkers.

I'm basing this hunch/theory/conspiracy off of DM's statements (grain of salt, yada yada yada) from the CTAD CC coupled with the fact that RVX has been quite quiet regarding the cognitive function results since the CC. I think this radio silence has to do with either waiting for the BT application for the cognitive aspect of Apabetalone to be ready to submit for BTD, or if that is already done, waiting to hear back from the FDA.

 

JMO, YMMV

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