Hope,
I think you're making an assumption that we don't know is true, namely that it was the company that held up the SAP. I believe it's more likely that the 4 regulators took their time, and yes they did ask for changes, but it's their way of doing things that adds months, sometimes years.
If people could come together and reach agreements, things like our SAP could be resolved in a few days. I'm not certain, but believe the FDA may take 60 days to consider practically anything. If they say, I want a comma after but in the preceding sentence, you add the comma and they get another 60 days to consider other changes. It's the game they play. The FDA would take 6 months to decide how to hard boil eggs. Companies don't criticize the FDA as they can always find ways to delay a company and cost them a lot of extra money.
I believe that NWBO and contracted people have been working on the BLA for months, they may be doing a rolling application where sections are submitted as they're completed and any changes required by the regulators can be done on the fly. If this is the case, they may have the entire document submitted by early in the third quarter, or sooner. Approval by one or more of the regulators would certainly be possible if that is happening.
It's been quite awhile since LG appeared on the podcasts, at that time he thought approval this year was possible. Some delays have probably occurred since then, but I don't know that work on the BLA was delayed by other delays, I still believe it's possible. Let's see what's revealed at the Annual Meeting, as well as when the TLD is issued, we may have a much better feeling after that.
Gary
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