hyperopia, good find, there is obviously a change in the company coming near term. If not, shareholders may have a problem. It is obviously true that if there is an expectation of approval to market coming in 2023 this conference would normally be a major event in the pre-approval marketing plan. We all know this is the expectation for 2023, so, how will DCVax be represented at this conference? It will be represented. I fully expect to know the answers by 12/31, and am assuming this news and more is backlogged behind mfg licensing at Sawston.
I think since Covid consumed all RA's that they have been challenged to keep up with their time commitments. There is reason NWBO expected Sawston licensing by EOY and I don't think there is a major issue after receiving authorization for clinical product, which requires the same quality system infrastructure. It is possible the Flaskworks transition has taken more submission time. It is normal to have a scale up transition included in a pre-approval mfg authorization and it will often include a higher level of automation. The key is that the processing utilizes the same principles as the clinical product process, or there could be more work required. In the case of Flaskworks it does not appear to me there are complicating factors, though routine requirements such as extractables and leachables sometimes uncovers some minor headaches, especially since the technology is new to this type of processing.
I think the expectation is shareholders will know the plan by 12/31 and DCVax will be represented at that March conference, all just my expectations.
Let us know if you see anything differently.
GLTA, Merry Christmas, Happy Holidays and Happy New Year!
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