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Wednesday, December 21, 2022 10:56:39 AM
Please consider, though, that while the two items, the PIP and the MAA, are submissions to the MHRA, they are not one and the same.
They did not PR the PIP protocol when they submitted it (which is why so many of us didn’t even know about it), but upon its approval. So if one were to suggest that the PIP and MAA were following the same path, we wouldn’t hear at all about when it would be submitted, but rather upon its approval. And that, I am fairly confident, is not how this process will play out.
I actually do think they began the process of submission some time ago, in that they are completing some number of modules, and that when these modules are completely filled, their application will be complete and they will announce at this time. That will then begin the clock of some number of days before the MHRA will accept or deny the application. Now that clock can be stopped when the regulator finds something is not complete or wants more information, which of course, would add to the time frame.
Anyhow, that is how I understand how the process will play out. I may be wrong, of course, and some things may also change from what I’d originally understood.
I think, though, that the time between submission and acceptance is likely minimal, at least in NWBO time. And perhaps that time may even be nonexistent, because if one is working on the various modules and won’t announce until the modules are completed, that would argue that everything, theoretically anyway, is, in fact in and so the application is actually complete, so the process can move forward to the next step.
They did not PR the PIP protocol when they submitted it (which is why so many of us didn’t even know about it), but upon its approval. So if one were to suggest that the PIP and MAA were following the same path, we wouldn’t hear at all about when it would be submitted, but rather upon its approval. And that, I am fairly confident, is not how this process will play out.
I actually do think they began the process of submission some time ago, in that they are completing some number of modules, and that when these modules are completely filled, their application will be complete and they will announce at this time. That will then begin the clock of some number of days before the MHRA will accept or deny the application. Now that clock can be stopped when the regulator finds something is not complete or wants more information, which of course, would add to the time frame.
Anyhow, that is how I understand how the process will play out. I may be wrong, of course, and some things may also change from what I’d originally understood.
I think, though, that the time between submission and acceptance is likely minimal, at least in NWBO time. And perhaps that time may even be nonexistent, because if one is working on the various modules and won’t announce until the modules are completed, that would argue that everything, theoretically anyway, is, in fact in and so the application is actually complete, so the process can move forward to the next step.
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