Morning fellow shareholders and onlookers.
When CE certification was granted the company used these words in the Trading halt:
"The Company requests a trading halt immediately, pending the release of an announcement regarding
its CE Mark Application."In this trading halt announcement:
"The Company requests a trading halt immediately, pending the release of an announcement
regarding an update on the Company’s regulatory approval process.
This smells like a China fast track regulatory application to me if it was in relation to the FDA it should state it just like they did regarding the CE approval application.. a lot has been happening behind the scenes in China, Tony has been going backwards and forwards and I have been sending messages to Tony and informing Brian as well about the need to apply to China now while we have this unique opportunity.. They have been well aware of the opportunity but couldn't elaborate hopefully this let's us know...
Hmmm but then on the flip side I look at the wording from the previous trading halt regarding TGA clearance it's stated this exactly what it does in this trading halt:
"The Company requests a trading halt immediately, pending the release of an announcement regarding regulatory approval."
So could be FDA but I see nothing listed on their website still... Not sure though if there is a lag in showing the company's approval until company has released details?
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/denovo.cfmExciting times that's for sure should get an update this week regarding Sanofi and potential FDA clearance and or submission to the Chinese regulatory bodies for emergency approvals...
BRING IT ON!!
Cheers
Red bar
