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24.0¢ paradigm biopharmaceuticals limited..

Ann: PAR Reports Phase 3 Clinical Trial Update, page-32

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Mangoman605

1,695 Posts.

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05/07/23

10:59

Post #: 68628343
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Yes Zenox, it seems risky to me, not to
include 2mg twice weekly in the dosing
study.

Originally posted by Zenox: ↑

I asked the same question a year ago and someone mentioned that Simon said 2mg/kg was still on the table, although there's been nothing in writing, so I would go by the official messaging and assume that it's only one of the doses from stage 1. I'm also not sure if we get a readout for stage 1 002 since that would involve unblinding the study. I'm also not sure how the DMC are evaluating overwhelming/underwhelming efficacy, so I can't read too much into us being allowed to continue the trial without modification. However, if we do get a readout and all doses are underwhelming PAR should be able to reapply to the FDA and request to dose at 2mg/kg.

On another note, today's announcement indicates that we've enrolled 468 patients into PARA 002 in ~ 18 months. So if all goes well, imagine where PAR will be in the next 18 months.

My views, dyor

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PAR Price at posting: $1.02 Sentiment: Hold Disclosure: Held
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