Too right. I get wanting to bag the FDA approval, but man i hate our fate resting ENTIRELY in only its hands. Hopefully, it doesn't turn out to be SI's white whale...
Going to other jurisdictions would of course be pricey, but local pharmaceutical partners, universities, etc., could be found to assist, and when (not if) approved for other indications (always thought not trialling for COVID ARDS in India, China, etc., during the height of the pandemic was a missed opportunity, for example), would provide both additional cashflows and more real world evidence of effectiveness and safety.
Get enough additional approvals and the weight of the evidence from other countries starts making a stubborn FDA look a recalcitrant luddite. Clearly, the proof of Japan's pudding alone hasn't been sufficient till now.
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