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Tuesday, September 14, 2021 1:24:51 PM
One of the interesting relationships we have with this situation is that NWBO owns the process and the process is basically licensed by Advent and Charles Rivers Labs. So the process, facilities, their maintenance, personnel and end product must all pass muster. Getting this all done at one site then replicated at all the others makes future inspections and certifications much easier. When to release news about progress in this or any area is a strategic question to be answered and the trade off with “accountability” is the possibility of “susceptibility” to attacks as we have seen before. Nothing wrong with asking for hard dates for the sake of accountability but leverage is maximized for good or for bad by management when hard dates are never given. Bears and shorts use this to their advantage when hard dates are not met because circumstances have changed or not made because others are involved who do not operate in sync with corporate time lines and might be biased towards working against them.
I think that the best investors can hope for when not given solid expectations is to anticipate what reasonable timelines might be based on historical evidence. I believe we are coming to the end of the reasonable timeline period for a journal article and that seems to coincide with expectations for manufacturing certification. Both of these events are dependent of the action or inaction of others while being prepared to put the final touches on a BLA or MAA once these others have acted is fully in the hands of NWBO. If NWBO has wasted all of this time by not preparing for a BLA/MAA submission then they deserve a great deal of heat but this will not be revealed until after the other anticipated events happen first. I believe they are prepared and that forward progress and accurate updates will be much more likely once the final roadblocks to manufacturing expansion are removed. Best wishes.
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