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Message: Today's wrap...my view

"I seem to recall something about BETonMACE patients opting to remain on Apabetalone if they wanted after the trial wrapped up....that all had chosen to continue taking the drug. My memory ain't what she used to be....did I imagine this?"

Growacet, the BETonMACE trial was originally designed (way back in 2015) to enroll 2400 patients, with first patients enrolled on drug for 2 years and last patients enrolled on drug for 1 year, for a median/average dosing period of 18 months. In other words, dosing was limited to up to 2 years (104 weeks) according to the original protocol.

At some point, the trial protocol was amended to allow for dosing beyond 104 weeks. I first noticed this in last summer's ERA-EDTA and AAIC posters that indicated that patients would be dosed up to 36 months. However, I don't think that this extension of dosing was specific to apabetalone; this extension of the allowable dosing period applied to both patients in placebo and apabetalone groups. IR confirmed to me via email that the trial protocol had been amended to allow for this extended dosing period beyond 104 weeks.

What you describe is an open-label extension, in which patients are no longer blinded and can voluntarily choose to continue on the drug. All participants would receive the test drug, and both the patients and investigators know this. I have never heard of there being an open-label extension in BETonMACE in any news release, science poster, science presentation, science symposium, science publication, corporate presentation, analyst report, clinical trial listing, etc. And you know me, I've been paying pretty close attention. So in my opinion, no chance of there being an open-label extension in BETonMACE.

BearDownAZ

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