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24.0¢ cynata therapeutics limited

Ann: DFU Clinical Trial Enrolment Complete, page-14

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13/04/24

10:10

Post #: 73327059
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Originally posted by bedger: ↑

You are correct. CEO hinted at it. Was of course mocked by the usual detractors who are not paying enough attention to changes going on the FDA. DFU is of course a pressing issue in the US with far too many amputations for a first world country:

"Diabetes is the leading risk factor for lower-extremity amputation in U.S. adults, with an estimated 150,000 diabetes-related major or minor amputations per year. Lifetime risk of any lower-extremity amputation among people with DFU is at least 19%"

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9797649/#:~:text=Diabetes%20is%20the%20leading%20risk,least%2019%25%20(56).

150,000!!! That's massive. Nearly 1 in 2,000 US people get amputations a year from Diabetes in the US, which is obviously rife. I think an accelerated approval on a phase II trial with a possible phase III confirmatory trial as a condition, a very real possibility.

Expand

This is a phase 1 trial.

All the P2 'successes' that were commercialised without a P3 were pulled from the market years later.

The last 'event' like that was 2018.

The CEO (KK) and you are deluded if you think the GVHD trial will commercialise on the P2 alone.

Anyway. Back to reality. This is a phase 1 trial. Try and pay attention.

CYP Price at posting: 18.5¢ Sentiment: None Disclosure: Not Held
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