The problem is that Regulatory circumstances are not always easily communicated with these brief email exchanges between RA's and citizens, who quite frankly are not the RA's main customers to serve in this capacity. The fact that Sawston has a Specials license but yet it does not yet have any commercial GMP license has bearing. The fact that NWBO has no commercial regulatory experience has bearing on an RA's approach as well as the first thing the RA wants to understand is how is the mfg site managed. If Sawston is applying for a CDMO GMP license that has bearing, particularly if there has been no commercial licensing to date, though having a Specials license as a CDMO also has bearing. I doubt there will be complete clarity on this aspect of the pathway until it is achieved.
Yet there is fundamental understanding that there are times MHRA permits overlap of MIA license and MAA application, as FDA does. Typically with FDA a sponsor company would not submit a BLA including a mfg site that has not been FDA GMP licensed and if the mfg site was new an FDA inspection would be requested prior to BLA submission.
Whether or not MHRA allows concurrency of MIA and MAA for a Specials License situation remains to be seen but I now think LP knows the rules as explained to them by MHRA regarding their particular situation and she stated the steps would be sequential. That is there must be a commercial license granted to the mfg site prior to the MAA submission and if Sawston had already been granted a commercial GMP license it would not be sequential but overlapped.
Regulatory can be a fuzzy space sometimes with gray areas open to interpretation and risk analysis such as another discussion between myself and another poster concerning a CBE-30 (implement after 30 days if FDA does not comment back) vs a PAS (prior approval supplement, wait for FDA approval) for a post approval submission for Flaskworks.
This means, IMO, it will be sequential, though there need not be significant time between the two and as soon as the commercial GMP license is granted the MAA can immediately follow.
Now, if these same rules apply if there is a rolling submission is another level of regulatory consideration and there is a rolling submission I think the requirements may be more flexible, though a requirement for a rolling review may be an already licensed mfg site or a requirement that a commercial GMP license must be granted at a particular stage of submission. We have no real indication of a rolling submission so I will stay with MIA, then MAA to immediately follow and priority review for shorter review period.
All IMO and GLTA
AI
