Ann: ImExHS Signs a Distribution Agreement in the US market, page-7

FDA: In the Investor conference call on 7 May 2019 IMEXHS Limited Investor Q&A for 1st Quarter 2019 Appendix 4C results: Managing Director & CEO: German Arango
this is paraphrased
Steve Maltby (Three Bridge Capital?) asked :
Can you give us an update of the FDA - you have applied, have the FDA come back with any feedback regarding concerns or questions
+ when do you expect loosely to that be approved?
German Arango
Done last week of 2018, the have in the process an initial 100 day window for additional information - this has already happened
After that they have an additional 80 days for their final decision - This 180 days falls in the last half of June we are still in the current regular process
Steve Maltby:
regarding the 100 days did they request they didn't have any additional questions or you didn't have to resubmit
German Arango
Yes they requested some additional information from us, we already did resubmit, the advisers have explained this to us.
we are currently in the regular process window of the 180 days.

*He sounds pretty confident in the process that the outcome will be successful

Announcement 4/7 - IMEXHS has applied for FDA 510(k) clearance, the outcome of which is expected shortly
Announcement 15/7 - • IMEXHS and IGMC Med will start reviewing market strategies while IMEXHS is waiting on its510(k) clearance notice from the US FDA.