Have used the aid of Ai to extract some transcript from the...

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 GBA in Germany. 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 GBA part of it :

G-BA Opportunity in Germany

Ryan Sudo: You’ve defined the G-BA opportunity in Germany as a significant inflection point for Oncosil. What stage are you at now, and why has this taken longer than expected?

Nigel Lange: The process with the German Federal Joint Committee (G-BA) has been quite complex and challenging, primarily due to political and legal issues rather than clinical ones. Here’s a detailed breakdown of where we stand and the reasons behind the delays:

Current Stage:

• We are working closely with the University of Cologne, which is leading the trial for the G-BA. The interest from hospitals in Germany has grown significantly over the past three years. Initially, 25 hospitals applied for the “NUB” status, then 33 the following year, and this past January, 84 hospitals applied. This clearly indicates strong interest and demand within the German healthcare system.

Political and Legal Challenges:

• One major issue is that we do not have FOLFIRINOX on our label as a comparator. The G-BA has raised concerns about conducting a trial with an off-label drug as a comparator, which has caused delays.
• The G-BA is an organization that reports to the German Parliament, making it inherently political. This means we have limited direct interaction with the G-BA itself. Instead, our interactions are mediated through the University of Cologne.

Efforts to Resolve Delays:

• We have applied both political and legal pressure to expedite the process. For instance, we have engaged with parliamentarians who have oversight over the G-BA. One of these parliamentarians, who has been quite supportive, expressed frustration over the delays and is pushing for progress.
• The primary legal issue revolves around the use of FOLFIRINOX, which is considered off-label in this context. Despite this, it remains the standard of care in Germany under the S3 guidelines, which German physicians follow for treating pancreatic cancer.

Strategic Importance:

• The G-BA approval is crucial as it would allow us to commercialize our treatment more broadly across Germany. If the G-BA study proceeds positively, it would enable us to negotiate commercial treatments with hospitals directly.
• Approval from the G-BA would significantly enhance our ability to treat more patients and expand our market in Germany. We estimate that around 35 to 45 hospitals have the necessary infrastructure and experience to treat pancreatic cancer patients with our technology effectively.

Timeline Expectations:

• Initially, we hoped to resolve the G-BA issues by the end of our current fiscal year (end of June). However, it seems likely that this will take a bit longer.
• We anticipate some updates from the parliamentarian who has been assisting us once the German Parliament is back in session. This political involvement is crucial to overcoming the bureaucratic hurdles we face.

Impact of G-BA Approval:

• A positive outcome with the G-BA would be transformative. It would not only validate our treatment within the German healthcare system but also serve as a benchmark for other European countries. The data from a successful G-BA trial could be used to support reimbursement applications across other European markets.
• Commercially, G-BA approval would allow us to rapidly expand our treatment availability in Germany, significantly boosting our revenue and moving us closer to our break-even point.

Conclusion on G-BA Process

Nigel Lange: To summarise, the G-BA process in Germany has been challenging due to political and legal complexities, especially concerning the use of FOLFIRINOX as a comparator. Despite these hurdles, we are optimistic and actively working on resolving these issues with the help of political allies. The potential approval from the G-BA is crucial for our expansion in Germany and will have significant positive implications for our business.