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nelskof

10/22/20 8:40 AM

#27428 RE: Clarnold #27427

Well said and very true. The Yahoo board is clamoring about this:

https://clinicaltrials.gov/ct2/history/NCT04453839?A=3&B=4&C=merged#StudyPageTop


https://clinicaltrials.gov/ProvidedDocs/39/NCT04453839/ICF_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.



I'm trying to make some sense out of it myself. Does that mean they enrolled 28 patients from 9/30 to 10/20? Seems really aggressive compared to the previous month BUT cases and hospitalizations have been spiking over the last month.
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aGuyUS

10/22/20 10:07 AM

#27437 RE: Clarnold #27427

Perfect response nicely said!
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threebabiesbusy

10/22/20 10:36 AM

#27449 RE: Clarnold #27427

Well said Clarnold. Great clarity on the what’s and why’s that are going on...
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aGuyUS

10/22/20 11:24 AM

#27464 RE: Clarnold #27427

Perfect clarity!
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KILLAZILLA

10/22/20 11:58 AM

#27471 RE: Clarnold #27427

So, it what way would it have any effect on the EUA app that was already filed? May only push back full approval, EUA still being considered with all the data they submitted with it.