Australian newspaper article, page-104

Holders really have been traumatised by prior CRLs, and so I can understand why it might make sense to reflexively assume that FDA is somehow not OK with the company passing commentary on the agreed and documented outcomes of a meeting. Absolutely fertile ground for the usual suspects of course, who seem to lose their minds over literally anything the company publishes, formally or otherwise.

Sentiment and quotes in the article are incredibly favourable, and certainly put paid to the myriad conspiracy theories promoted on here by various non-holding entities. For what its worth, I think the simplest explanation here isn't that the company has somehow made a mistake, or SI is somehow speaking out of turn, but instead that the data provided by the company is actually incredibly compelling, FDA concurs with this, and the official meeting minutes provided to the company also reflect this.

Something has shifted at FDA. Not long until we find out exactly what that is.