1) BOT received a CRL - it indicated the only negatives related to NON-clinical matters - meaning, IF they have all been adequately addressed, the drug should be approved - the FDA flagged NO drug related issues in the CRL.
2) All royalties are now owned by BOT - except a master 5% royalty to the lab that first developed the drug candidate - BOT bought out all the previous commercial promoters royalties - ie, all royalties now 95% owned by BOT! A VERY Wise move!!!!
I hope BOT approval drops in the next few weeks....it should be a bit early...but that's just wild speculation on my part....but given it's all packaging/labelling/diagram issues.....fingers crossed!
Sofdra - Post approval royalties, costs and earnings, page-13
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