Monday, May 13, 2024 4:20:43 PM
They never stated there was no RFI. What they previously stated, in my own words, is that their MAA was validated, passed validation and confirmed validated. They never needed to modify the MAA after submission to get confirmed validated.
Gary, any phase I RFI would have come after the MAA was confirmed validated.
The only way what Les said makes sense, imho, is that this moves to fall because NWBO asked for an extra 60 days on top of the 60 days they already had to respond. Les said as of May 9, there is no bad news to report.
In other words for him to say the 150 day accelerated is on track, he is allowed to discount the additional 120 days that are not counted on the 150 day clock.
That’s why Les can say it’s still accelerated and on track.
Gary, any phase I RFI would have come after the MAA was confirmed validated.
The only way what Les said makes sense, imho, is that this moves to fall because NWBO asked for an extra 60 days on top of the 60 days they already had to respond. Les said as of May 9, there is no bad news to report.
In other words for him to say the 150 day accelerated is on track, he is allowed to discount the additional 120 days that are not counted on the 150 day clock.
That’s why Les can say it’s still accelerated and on track.
Recent NWBO News
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- Form 8-K - Current report • Edgar (US Regulatory) • 10/30/2025 08:40:05 PM
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