(Total Views: 307)
Posted On: 10/06/2020 1:16:37 PM
Post# of 36566
So if the Pre-IND is approved, and the BK deal is formally inked, I would see the path forward as this (correct me where I'm wrong!):
- Peptides/blood work should be finalized shortly (or already has been). Any remaining work would presumably be paid for by BK, as they are now signed to pay for development (?) or will be released using the $2.5MM up-front money from the deal
- Trials should be put out for patient enrollment, on BK's dime, in Malaysia, following the Pre-IND guidance
- The data from these Malaysian trials should be applicable to a future NDA/EUA here in the US w our FDA
- Once our FDA approves a vaccine, the Malaysian FDA presumably review the data but likely has few issues if our FDA has cleared it.
Does anyone understand anything different from that? My biggest assumption there is that we wouldn't have to do trials in the US if the data from overseas is good and the trials meet the IND... is that correct?
- Peptides/blood work should be finalized shortly (or already has been). Any remaining work would presumably be paid for by BK, as they are now signed to pay for development (?) or will be released using the $2.5MM up-front money from the deal
- Trials should be put out for patient enrollment, on BK's dime, in Malaysia, following the Pre-IND guidance
- The data from these Malaysian trials should be applicable to a future NDA/EUA here in the US w our FDA
- Once our FDA approves a vaccine, the Malaysian FDA presumably review the data but likely has few issues if our FDA has cleared it.
Does anyone understand anything different from that? My biggest assumption there is that we wouldn't have to do trials in the US if the data from overseas is good and the trials meet the IND... is that correct?
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