Hi, guys. I've been following OSL for 7 years now. Still patiently waiting for commercialization.
My understanding of the announcement is that the TGA wants data from a randomized clinical trial which it knows OSL does not yet have. I guess they're taking a wait and see approach. OSL has been planning to do an RCT all along - it is a requirement for public reimbursement in Europe, and the FDA also wants this type of evidence.
Nigel Lange (26/2/21): "we’re currently sitting with results from a single-arm trial, which is the PanCO study. Reimbursement from the public sector requires a hard endpoint but that endpoint also has to have a comparator i.e., the OncoSil device versus something else. Subsequently, we need to be able to go down a clinical development pathway, which will mean that we will need to conduct a randomised trial."
Regardless of this, they can still sell the device to private patients in Europe. Hopefully we'll start to see some growing cashflows from these sales which will take some of the pressure off as they prepare for another study.
OSL Price at posting:
6.3¢ Sentiment: Hold Disclosure: Held
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