Ann: FDA IND Approval for Phase 3 Study of DMX-200 in FSGS, page-49

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betheball

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26/07/22

18:24

Post #: 62738210
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Originally posted by Owl vs Fox: ↑

Hi BTB,

This is awesome news! How many patients do we need for Interim Analysis again to take to the FDA? It’s n=72 & if you take into account we now have 44/75 actively recruiting, even if not yet recruiting PIs will be identifying suitable patients, until site initiation is completed & the green light given to commence - this isn’t even two patients per trial site in an Orphan Status (Rare disease) currently.

If all come onboard soon it’s roughly <1 patient per site. 3 patients per site is totally do-able to run smoothly if needed, event with multiple drug trials ongoing.

Something else also important is the “Intent to treat” population & that FSGS appears to be more common in black people & also those of Hispanic heritage. So take a look at trial sites, there is a lot of disparity in who gets recruited & benefits of clinical trials, white people suffer as well, but we want a representation of the FSGS sufferers in our trial & that may be interesting to you, as the FDA & World-Wide conferences are very much talking about inclusive clinical trials.

It’s a little different to REMAP-CAP & CLARITY 2.0 in that this Ph3 is Sponsor Lead (Dimerix) & an excellent Clinical Research Contract Organisation that deals with the day to day running of the trial, data collection portals & trial equipment. They are used often by Big Pharma trials also.

There has been a big shift in accommodating clinical trials with CRO’s & COVID-19, not only to support trial sites should they be affected by COVID-19, but also patients as well, to not miss visits (contingency put in place) with Decentralisation, that will not affect our data. A lot has changed in the last 2.5 years! We have been faring well. No reason we won’t on DXB also. It’s a vulnerable population with COVID-19, but so are other clinical areas.

This is great news!

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Thank you OvF

Lets hope so and given that a relatively significant number of patients stayed on the drug post ph2 trials, then the more the merrier.

I’m sweating on the Covid results due any day now.

Not getting any younger!

cheers

DXB Price at posting: 15.0¢ Sentiment: Hold Disclosure: Held
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