onlyGreen Whistle gets the Green Light

useInvestor Presentation

Gordon Naylor - Chair

Brent MacGregor - CEO ersonal3 March 2022 - 10am AEDT

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onlyuse ersonalDisclaimer

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Removal of Full Clinical Hold allowing Phase III trial to commence

The Journey So Far

only First request for FDA Meeting in February 2016 Penthrox Clinical Trial placed on Hold in August

2018

Formal Review (Type C) Meeting in January use 2021

MVP Clinical Hold Response Submitted in December 2021

ersonal Numerous technical exchanges leading to……

3

FDA Feedback on 1 March 2022

"We have completed the review of

your submissions and have concluded that the clinical trial may be initiated"

Trial Specifics

onlyuse ersonal4

Protocol - treatment of moderate to severe acute trauma pain in pre- hospital participants

  • First patient enrolled late 2022
  • Expected study duration - 2 years
  • 10 sites to be selected
  • 200 patients in total
  • Study costs circa A$12m

Key Takeaways

only

use

ersonal5

The lifting of the hold is unconditional

In anticipation we had commenced clinical trial preparations

We expect registration and launch in FY26

Selfie is the intended launch product

A US launch will drive a second wave of expansion succeeding the current EU growth

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Medical Developments International Limited published this content on 02 March 2022 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 02 March 2022 22:18:11 UTC.