Monday, July 28, 2025 1:52:42 PM
You’re misreading what was actually claimed.
No one said the approval must come by mid-August. What was stated is that we are likely already in the labeling phase, and that if labeling began around July 16, as inferred from the NICE letter dated July 15, then a three to four week labeling window puts us into early to mid-August for completion. That is not wishful thinking. That is how long labeling typically takes in MHRA approvals, particularly under the ATMP framework.
The suggestion that CMC or Flaskworks could still be under review is speculative on your end. The most recent MHRA facility inspection was in August 2024. Flaskworks has been under MHRA review for over two years. If there were unresolved validation or QP issues, the product would not have been accepted for review, and Advent would not be manufacturing patient-specific doses under SI 87 authorization.
The July 15 NICE letter confirmed that no submission had been made because a draft SmPC had not yet been received. That is the trigger. Once the draft SmPC is issued by MHRA, NICE can accept the submission. If NWBO has not submitted to NICE as of July 15, then logically, they had not yet received the draft. That is why labeling is the only step that fits.
So no, this is not AI structured or speculation dressed up as inference. It is regulatory process traced backward through official documents. Your framing reduces everything to guesswork, but the actual facts support the timeline.
And just between us, are you afraid I’m right? Is that what this is? If you were confident I’m wrong, you’d leave it alone. But maybe your crew hasn’t finished accumulating yet and still needs to keep the price suppressed just a little longer. That would explain the sudden urgency to cast shade on logic that actually holds up.
Also, if your only goal is to “sell this turt,” then maybe let those of us focused on regulatory analysis do the heavy lifting without the sarcasm. The process is real. The inference is grounded. And the timeline is holding.
And the only logical conclusion for all of you posting this over and over again is this: either you are not finished loading, or you are short. And if it’s the latter, then you are really going to regret it.
No one said the approval must come by mid-August. What was stated is that we are likely already in the labeling phase, and that if labeling began around July 16, as inferred from the NICE letter dated July 15, then a three to four week labeling window puts us into early to mid-August for completion. That is not wishful thinking. That is how long labeling typically takes in MHRA approvals, particularly under the ATMP framework.
The suggestion that CMC or Flaskworks could still be under review is speculative on your end. The most recent MHRA facility inspection was in August 2024. Flaskworks has been under MHRA review for over two years. If there were unresolved validation or QP issues, the product would not have been accepted for review, and Advent would not be manufacturing patient-specific doses under SI 87 authorization.
The July 15 NICE letter confirmed that no submission had been made because a draft SmPC had not yet been received. That is the trigger. Once the draft SmPC is issued by MHRA, NICE can accept the submission. If NWBO has not submitted to NICE as of July 15, then logically, they had not yet received the draft. That is why labeling is the only step that fits.
So no, this is not AI structured or speculation dressed up as inference. It is regulatory process traced backward through official documents. Your framing reduces everything to guesswork, but the actual facts support the timeline.
And just between us, are you afraid I’m right? Is that what this is? If you were confident I’m wrong, you’d leave it alone. But maybe your crew hasn’t finished accumulating yet and still needs to keep the price suppressed just a little longer. That would explain the sudden urgency to cast shade on logic that actually holds up.
Also, if your only goal is to “sell this turt,” then maybe let those of us focused on regulatory analysis do the heavy lifting without the sarcasm. The process is real. The inference is grounded. And the timeline is holding.
And the only logical conclusion for all of you posting this over and over again is this: either you are not finished loading, or you are short. And if it’s the latter, then you are really going to regret it.
Bullish
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