"I have been trying to research how this approval process worked for SRX with not much luck."
The regulatory pathway for SRX was very different. (1) SRX is marketing a delivery method (SIRT) and not a device; (2) SIR-microspheres are Yttrium-90 beads, which is a known device, and hence SRX would only need to show that the SIR microspheres are comparable to Y-90 beads that were already in use, in the marketplace, and known to be effective; and (3) multiple clinical trials in the mid 90s
OSL Price at posting:
12.0¢ Sentiment: Sell Disclosure: Not Held
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