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#OncoSil receives EU Mark
Added 2 months ago

01-Apr-2020:  Oncosil breakthrough device receives CE Marking approval

After so many years of promises and delays, plus BSI knocking OSL back on their CE Mark application 12 months ago, you'd almost be forgiven for thinking this was an April Fools Day joke.

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#Bull Case
Last edited 3 months ago
  • OncoSil has upside similar to Sirtex (SRX) when they were at this early stage, except OncoSil has better management.
  • OSL's Chair is Dr. Chris Roberts, ex-boss of Cochlear (COH).
  • A number of OSL's senior managers / executives are ex-SRX.
  • OSL is about to get their CE Marking to allow their OncoSil™ treatment to be sold into Europe (the EEA: European Economic Area) as a treatment for pancreatic cancer - this calendar year.  That will be followed by FDA approval for USA distribution and sales.  Next, they will be seeking approval as a treatment for Liver Cancer.  There will be other cancers that the OncoSil™ procedure will be able to be used for in the future also.
  • OncoSil™, is comprised of OncoSil Phosphorous-32 Microparticles and OncoSil Diluent.
  • OncoSil™ is an active implantable (radiological) medical device intended for use in brachytherapy, where cancer is treated by the insertion of a pre-determined dose of beta radiation emitting isotope directly into the cancerous tissue via Endoscopic Ultrasound (EUS) guidance. 
  • The beta particles emitted by OncoSil™ travel a short distance in tissue causing direct damage to cancer cell DNA, which renders them incapable of further cell division and proliferation. Through this mechanism, OncoSil™ is able to stop cancer cells from multiplying and ultimately shrink tumour masses when the cells eventually die. 
  • Brachytherapy targets tumours more precisely and delivers higher tumouricidal doses of ionising radiation, while reducing the radiation exposure in the surrounding healthy tissues than external beam radiation therapy. Brachytherapy may cause fewer side effects than external beam radiation, the overall treatment time is usually shorter with brachytherapy and the procedure can be conducted on an out-patient basis.
  • While the OncoSil™ procedure doesn't usually cure the patient, it is an effective treatment for halting tumour growth and shrinking tumours, which has allowed some patients to have surgical resections of their pancreas - the only known cure for pancreatic cancer - when those patients were deemed unsuitable for surgical resection prior to having the OncoSil™ procedure - so it can CONTRIBUTE to a cure.
  • Tragically less than 5% of people diagnosed with pancreatic cancer currently survive for 5+ years post-diagnosis.  The mortality rate is very high.  There is a clear unmet medical need here.
  • OncoSil™ works, and will be selling in the UK within 12 months.

Disclosure:  I hold OncoSil (OSL) shares.

10-Jul-2019:  Update:  That was 4 months ago.  I sold out on the day they resumed trading after they made the announcement that made it clear that the BSI was NOT going to be granting OSL a CE Mark for their pancreatic cancer treatment based on the studies completed to date by OncoSil (OSL).  Further studies will be required, which will take time and a lot more money.  That will mean cap raisings, and a lower share price.  I didn't sell on the open when they recommenced trading - as they opened at below 3c, but I sold later in the day when they were higher (at 4.8c).  They've traded as low as 2.1c and as high as 9.5c during the past 15 weeks, and they're now back at 5c.  Not being an expert in the field of oncology or medical device approval processes, I trusted that what OSL management told us (the market) was the truth, or at least what they themselves believed to be the truth.  Having trawled through pages of hotcopper posts looking for answers (not something I recommend, it's horrible!!), I have come to the conclusion that OSL management have lied to us.  My view is that they are either dishonest or incompetent, and either way - I don't want to own OSL shares again.  The massive salaries they were drawing when the company had zero revenue - and the bonuses they were receiving - should have been a big red flag.  I was blinded by my unbridled optimism for OSL, which I thought was as close to a "sure thing" as you could get.  Between RCR and OSL, FY19 wasn't one of my better years!

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