I think it has certainly been an established practice for foreign regulators to wait for FDA action before granting their own approvals. I think we saw an example of that with the Philippines.
But I also think, for management, that the tide may be turning. They indicated in their May 13th PR that they may stop producing lenz in mid-2021 if, "... an EUA or CMA for lenzilumab is not received by" then.
These guys have been keeping the FDA updated. They're participants in the regulatory compliance of the development. They knew immediately, and reported immediately, the topline data. They had their Type B meeting within two weeks of that, and if that is all true, then the FDA has now had a month to decide whether or not to grant an EUA, assuming they did not need even more information via the application.
We are sponsored by the Department of Defense. I think that signals the importance of this product to the US government. This public notice of the company's intent is now communicated to the DOD, as well as to Congress. Let the FDA play their games and see how that works out when the focus of other, more powerful entities, including those with FDA oversight, are aware of any delays by them in getting our product approved.
AI
