Now the same for FDA ( sorry Ryan, I have corrected your name as...

Now the same for FDA ( sorry Ryan, I have corrected your name as well, to Soutar, not Sudo sorry an Ai glitch )

Have used the aid of Ai to extract some transcript from the Webinar, and then more Ai to create a summary of that with particular focus on FDA application. What is printed below is not word for word what the CEO said, it is rather an Ai summary which is quite accurate I believe - but DYOR, do not rely on this Ai generated webinar summary to make investment decisions, best you listen to the Youtube recording instead.

here is the Ai summarised FDA application part of it :

FDA Filing in the US

Ryan Soutar: Could you update us on the progress with the FDA filing in the US? Why has the progress been slow, and where do we currently stand?

Nigel Lange: The FDA process has been quite involved, requiring us to address numerous medical questions. Initially, we made a filing, but it's essential to understand that dealing with a regulatory body like the FDA involves prescriptive timelines over which we have no control. The goal was to simplify our existing dossier while framing the questions around it more clearly to make our case effectively.

Medical Questions and Review: The questions we had to address were predominantly medical rather than regulatory. These needed to be reviewed and refined with the help of experts and key opinion leaders in the field. The complexity of these medical questions significantly contributed to the delays.

Humanitarian Device Exemption (HDE): We are pursuing approval under the Humanitarian Device Exemption (HDE) program. This specific pathway is designed for devices that address unmet medical needs. Under the HDE, we do not need to prove the product's efficacy but rather demonstrate its probable benefit to patients. This means establishing a strong safety profile that satisfies the FDA's requirements.

Key Points in FDA Filing:

1. Safety Profile: Ensuring that the device is safe for patients is paramount. The FDA needs to be assured that our device will not pose undue risks to the patients.
2. Probable Benefit: Instead of proving efficacy, we need to demonstrate that our device offers probable benefits to the patients it is designed to help.
3. Medical Expert Involvement: We have engaged with key opinion leaders who are assisting us in addressing the FDA’s medical queries. Their expertise and validation are crucial in making our case stronger.

Timeline and Future Steps:

• We are optimistic about being able to release some news regarding our progress with the FDA soon. However, it's difficult to provide a specific date as the regulatory process is not entirely within our control.
• A face-to-face meeting with the FDA is anticipated to be a critical next step. The FDA is becoming more receptive to in-person meetings, which can be more effective than virtual ones for discussing complex medical and regulatory issues.
• We hope to establish a clear pathway forward, even if it involves some degree of compromise, such as a small post-marketing Phase 4 study to secure approval.

Expectation of FDA Approval:

• The most crucial outcome we seek is FDA approval. This approval is not just about entering the US market, which is the world’s most lucrative, but also about the global resonance of having FDA approval. It significantly enhances our credibility and marketability in other countries.

Potential Impact on the Business:

• FDA approval would be a significant milestone for us, opening doors to new markets and increasing our ability to expand our reach.
• It would also enhance our position in negotiations with other regulatory bodies globally, as FDA approval is often seen as a gold standard in medical device approvals.

Additional Context on the FDA Process

Ryan Soutar: Just for investors' timeline, when you say not so distant future, are we talking within the next six months, the next 12 months, or a shorter period?

Nigel Lange: We are aiming for an update before the end of this calendar year. The timeline is somewhat fluid due to the regulatory process's nature, but we are working diligently to move things forward as quickly as possible.

Conclusion on FDA Process

Nigel Lange: To summarise, the FDA approval process has been slow due to the need to address detailed medical questions and navigate the regulatory framework. However, we are optimistic about our progress and look forward to providing more updates soon. FDA approval is crucial for us, not just for the US market but for its global implications, and we are committed to achieving this milestone.