It should be clear that NWBO has no influence on how long the British authorities will take to approve the MIA. Once they've made the inspection, unless they've requested changes, it's up to them. If they did request some change, and to reinspect after it's been made, then it would be up to Advent to get it done. NWBO may have some influence with Advent, but again we don't know that any change has been requested from them, or if it has, if it requires a reinspection. We do know that inspectors have reauthorized the facility for making vaccine for compassionate use, it's hard to believe that there is something of significands between compassionate and commercial use.
I believe it's just a matter of time and very shortly after we get the authority our application for approval will be filed with the British authorities. The question may be, will the company file for anywhere else based on the Sawston facility alone, or will any other production capacity be announced anywhere else.
Biotech's generally don't tell stockholders when the file with regulators, they announce when the regulators accept those filings, and then when they act upon them. In the case of the U.K., they target to act on applications for approval in 4 months or less. The U.S. FDA targets their PDUFA date 6 months after the filing for a product targeting terminal and other serious diseases.
Gary
Bullish
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