I can't believe how long it has taken to deal with the CRL, but we are finally here and on our road to commercialisation
We've lost a lot of SHs over this elongated and painful CRL process.
With only stubborn MSB'ers remaining.
Yes, nothing is guaranteed with the FDA but IMO we've seen the worst of the SP.
HOPE is back for long suffering MSB'ers - phew - I've had enough of the negativity!
Stuff the trolls! Stuff the Sharts (they've mostly exited anyway)
As an MSB'ers, we can look forward to blue sky SP as I can see the following:
1. FDA Accept Rynoncil BLA - up to 14 days wait
2. Ryoncil product approval - up to 6 months, but should be shorter with ODAC approval already done
3. Insurers reimbursement news - this is likely to happen before #2
4. Commercialisation, First patient etc... - Q1 2023?
5. Other huge indications
GL MSB'ers - I'm looking forward to see our days/ weeks/ months/ years in the sun
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