News Focus
News Focus
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bas2020

05/03/18 12:53 PM

#149276 RE: hapit #149275

Isn't the Rett trial going to be mostly from patients' homes? Can you elaborate?

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McMagyar

05/03/18 1:03 PM

#149278 RE: hapit #149275

Take it one step farther..

The time between trial start and fully enrolled.. will not be long either..
On a 12 week study...


Short away shorty mc short short..
Your time to pay the band arrives soon enough. Hope the band of distorters enjoyed their dance on the floor of maladies...
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LakeshoreLeo1953

05/03/18 2:01 PM

#149291 RE: hapit #149275

Are they interviewing CRO(s)?
That would REQUIRE protocols for legit bid.

OR

Is the Company seeing what CRO(s) may be interested
in an as yet non specific trial?

Parsing the information from this Company continues to
be an issue. Then again, I guess everyone is correct no
matter how they interpret the "News".
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Amatuer17

05/03/18 2:14 PM

#149294 RE: hapit #149275

In most cases, company also needs to specify primary site in the IND application. The primary hospital site needs to agree to the trial and controls - all those details need to be included in the IND / protocol submission.

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Bourbon_on_my_cornflakes

05/03/18 2:33 PM

#149300 RE: hapit #149275

Great work Hapit.
Useful and positive info that will take real work to spin negatively.

Fact is AVXL is methodically proceeding on multiple fronts to starting trials.

TRUST THE PLAN
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plexrec

05/03/18 4:09 PM

#149311 RE: hapit #149275

hapit--"I had a long conversation with Clint today"--good stuff---thanks for your efforts !!!
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hokieal

05/04/18 11:14 AM

#149408 RE: hapit #149275

Found an interesting article from last year on some general observations for study start up delays. Based on the part I quoted below, it is a good sign if we are in the site visit portion because it means we have completed (or come close) all of the work leading up to this stage. Feels like we are getting close now.

Accelerating Study Start-Up: The Key to Avoiding Trial Delays

A study conducted by the Tufts Center for the Study of Drug Development determined that it takes eight months, on average, to move from pre-visit through to site initiation,1 out of which nearly six to eight weeks on an average are for sending feasibility questionnaires, having them completed, and receiving responses.2

Quite often, the finalized site selection itself eventually becomes a rushed process, whereby hundreds of investigators/sites across the globe are selected over a short span in an attempt to hasten trial start-up. As a result, poor selection of trial sites becomes a problem during trial conduct, and reportedly increases the cost of clinical trials by at least 20%.