1/6 #SNG EUA Process - @US_FDA

“The FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, *treat*, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

2/6 In determining whether to issue an EUA for a product, the FDA evaluates the available evidence to determine whether the product may be effective and also assesses any known or potential risks and any known or potential benefits.” (Data) #SNG

3/6 If the product meets the effectiveness standard and the benefit-risk assessment is favorable, the product is made available during the emergency.” (COVID deemed health emergency)

4/6 Taken from https://www.fda.gov/news-events/press-announcements/fda-takes-additional-action-fight-against-covid-19-issuing-emergency-use-authorization-second-covid

5/6 @ProfWilko and his colleagues will constantly be assessing the data and the effectiveness of the treatment. This will include safety data which will be imperative before any EUA submission. Data is king. #SNG

6/6 My hope is that we will see very early on how effective this treatment can be in saving lives and we can get it to everyone who needs it. @Synairgenplc #SNG