Approval by GBA would actually take some time to translate into cashflow, because the trial needs to be set up.
Approval of Oncosil in individual hospitals by health funds would probably give faster cashflow.
Unlike US where you can't do anything at all without the FDA, but FDA approval comes with automatic reimbursement. And they are still working on FDA.
It's pretty obvious that German approvals (GBA or other) or any sort of FDA approval for any indication would dramatically improve the company's prospects, and share price, and thus improve the terms on which they cut a deal or raise some cash.
I like the liquid radiotherapy story, but maybe it's too big a product for a little company like Oncosil to manage worldwide. Sirtex had the advantage of an early FDA approval on a very small RCT in a basically palliative indication, and thus steady strong positive USD cashflow before it undertook pivotal OS trials (which it failed, and could afford to fail). I think the product has a place.
If I bought Oncosil I would start 2 RCTs: 1. in patients with local and metastatic disease and 2. in patients already planned to undergo surgery as pre-op adjuvant therapy (vs chemo). The first would recruit quickly, and I bet FDA would approve quickly and its uptake by oncologists would be really fast. And therefore some cash would flow and keep the lights on
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- Ann: 84 German hospitals can negotiate fee for Oncosil device
Ann: 84 German hospitals can negotiate fee for Oncosil device, page-19
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