Savvyinvestor,
There are 4 patients with PR not 2
DCR @ 16 weeks is a standard oncological endpoint.
I respect that you are a well versed in cancer research and surgeon but this may not necessarily translate to understanding device development and the rules surrounding it.
OSL is a local implantable device. OSL needs to show Overall survival (OS)for approval and it needs to demonstrate a local ant-cancer effect.
The regulatory approval standard for initial approval – local device needs to show a local tumour impact – 20 % PR(4/20) and 30% (6/20) resection rate and substantial tumour volume shrinkage up to 73% and DCR rates of 87% at 16 weeks are all highly relevant and significant results demonstrating local anti-cancer impact for a local device!
Obviously it will take time to show local progression free survival (LPFS) and this will probably take another year. So fair enough you can wait for 12months but you may not buy back in at these levels. But that is the risk/reward equation of investing in the market.
Each to their own and it is fair enough if you choose to wait. In Science we should always start with a skeptic mind.
Thanks
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Savvyinvestor, There are 4 patients with PR not 2 DCR @ 16 weeks...
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