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Re: nelskof post# 27466

Thursday, 10/22/2020 12:36:16 PM

Thursday, October 22, 2020 12:36:16 PM

Post# of 44695
Study Protocol and ICF document in the Open Label CT EAP Trial updated On July 27,2020 was a combined single document. 39 total pages long with ICF form beginning on page 26 of the document The ICF is 14 Pages long in this version

https://clinicaltrials.gov/ProvidedDocs/39/NCT04453839/Prot_ICF_000.pdf


On the same page (Page3) as the 10/20/2020 ICF we she in the 7/27/2020 version this wording

A randomized placebo-controlled trial of Aviptadil is underway that has enrolled more than 60 patients. In that trial, no drug-related serious adverse effects were seen and an independent data safety board determined that the trial should continue with a clear possibility that a difference between RLF-100 and placebo will be seen.




here's the Side by comparative of EAP Clinical Trial 7/27/202 with 10/20/2020 Here to have access to BOTH PDF's
https://clinicaltrials.gov/ct2/history/NCT04453839?A=3&B=4&C=Side-by-Side#StudyPageTop

IN the 10/20/2020 update there are now 2 seperate documents One Study Protocol the other the ICF form separated out At this link includes the quote your guys found. This document is still 14 pages in length as it was in the 7/27/2020 combined document

https://docs.google.com/viewer?url=https%3A%2F%2Fclinicaltrials.gov%2FProvidedDocs%2F39%2FNCT04453839%2FICF_002.pdf

“A randomized placebo-controlled trial of Aviptadil is underway that has enrolled more than 130 patients. In that trial, no drug-related serious adverse effects were seen and an independent data safety board determined that the trial should continue with a clear possibility that a difference between RLF-100 and placebo will be seen.”



This is not a mistake.!!!! It's definite change between the previous version and this updated ICF
THIS IS NEW!!!!!!!! MOST DEFINITELY!!! OUR Dr. J. is PRO!