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Uboy

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05/11/21

18:30

Post #: 57356663
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Originally posted by BoomCrashOffera ↑

Great find shyaam. Appreciate the information and analysis. It would be nicer if the results from the small P2a cohort were less dispersed. Three out of the nine patients (33%) fell outside the 95% confidence limits of -1.33 to 3.11.

Just for reference to others interested and to save them diiging up the results, the PUL 2.0 scores in the P2a - 24 week - study were:

Patient # PUL 2.0
01-001 +2
01-002 +2
01-003 0
01-004 +2
01-006 -3
01-008 +7
01-009 0
01-010 0
01-011 -2

I think the positive outcome from the trial was that 7 out of the 9 patients had no deterioration in their strength, and four out of the 9 actually increased, which was unheard of, I think, until this trial.

Anyway, the disparity in results and the small sample make the larger trial a little riskier than I would like (a shoo in would have been nice), given your findings on the likely placebo mean for 6 months of -1.09 (with steroid treatment or without?).

Expand

Boom,

Also worthwhile reading the annn from early / mid 2020 with additional data from P2A.

Has the MRI results showing reduction in fat fraction % over the course of 24 weeks.

That is unheard of…natural history shows a degradation in muscle ie. More fat over time

Slowing disease progression is considered a win!

BUT actually improving muscle function is unheard of.

The science is good.
.

ANP Price at posting: 22.5¢ Sentiment: Buy Disclosure: Held
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$15m cap raise Fresh Equities at 24c, page-552

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