OSL 11.1% 0.4¢ oncosil medical ltd

Thanks @Eey Ore for the link. Unfortunately the 21 page PDF is...

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    Thanks @Eey Ore for the link. Unfortunately the 21 page PDF is in German, but it contains a few lines that got me super exited! The decision for G-BA to approve a fully funded trial of OncoSil is a major tunning point in the SP. OSL has been given a new lease of life.

    1. G-BA is is virtually EU's FDA. If it approves OncoSil for reimbursement under the German healthcare system, UK and other EU countries would give it favourable consideration under their respective national healthcare schemes. At around $25K per treatment, it is a big ticket item to be funded by any government UNLESS it is proven to work with current pancreatic cancer treatment regimens (more on this later).

    The Federal Joint Committee

    The Federal Joint Committee (G-BA) is the highest decision-making body of joint self-government in the German healthcare system. In the form of guidelines, it determines which medical services the approximately 73 million insured persons can claim. In addition, the G-BA decides on quality assurance measures for practices and hospitals.


    2. OSL has had insignificant sales since EU's CE-Mark approval. What appears to have OSL bogged down is the clinical trial was based on the older chemotherapy Gemcitabine (FDA 2011) as an adjuvant. I suspect TGA had asked if OSL could provide trial results using Folfirinox (FDA 2015) instead. One could have heard the loud screaming from North Sydney HQ, "You got to be joking! That's another clinical trial mate!". This could explain why the TGA application was dropped. G-BA came to the rescue - a free ride with $$$ to fully fund a new trial using Folfirinox or Gemcitabine or Gemcitabine+nab-paclitaxel combo. See Page 8 of the PDF "Main reasons for the decision" on G-BA's web site. I have the juicy bit highlighted in the English translation below.
    https://hotcopper.com.au/data/attachments/4212/4212738-a7a0e149bde8bb05163fcec9b3ce44ea.jpg3. Folfirinox could increases Oncosi's efficacy and therefore chance of success as it has proven to be more effective than Gemcitabine. That's why it is more commonly used in current Pancreatic cancer treatment regimes. It would be difficult to convince the oncologists and clinicians to go back to an older and less effective chemo drug Gemcitabine in order to recommend Oncosil to a patient.

    https://hotcopper.com.au/data/attachments/4212/4212754-5a70ab875bd50a74a5cfb591beff40e4.jpg
 
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