[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]  Andrew Caravello, DO [@andrewcaravello](/creator/twitter/andrewcaravello) on x 1088 followers Created: 2025-07-15 20:44:28 UTC 📄 Why the July XX NICE Letter Strongly Suggests $NWBO Is in the Final Step: Labeling A step-by-step breakdown for those trying to decode the regulatory silence Let’s walk through what the July XX NICE letter actually says, what it doesn’t say, and why all roads point to one conclusion: MHRA labeling is happening right now. 1️⃣ What the Letter Says “NWBO is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA.” “The company is not yet in a position to provide their evidence submission…” This tells us two things: ✔️ NWBO is still in active dialogue with the MHRA ✔️ NWBO cannot proceed to the next step (NICE submission) yet 🚫 2️⃣ What It Doesn’t Say It does not say: ✖️ MHRA requested more data ✖️ The company failed a review ✖️ The process is paused or delayed If anything were wrong, the wording would flag that. Instead, we’re told they’re “fully engaged.” That’s a live channel, not a red flag. ⏱️ 3️⃣ Let’s Talk Timing 📅 MAA submitted: December 20, 2023 📅 NICE response: July 15, 2025 That’s X months later, and most MHRA scientific reviews are completed within 150–210 days. Which means: 💡 The scientific evaluation is almost certainly done. 📋 4️⃣ What Happens After Review? The final stage is called labeling, technically known as finalizing the SmPC (Summary of Product Characteristics). This is the regulatory instruction sheet. It defines: 🧬 What the product is approved for 💉 How it’s used 👥 Who it’s for ⚠️ Warnings and limitations This phase is not public, but it’s busy. And it happens only after MHRA has internally said “yes.” 🧷 5️⃣ Why the “Not Yet in a Position” Line Confirms It NICE doesn’t accept a submission unless the final label has been issued. Their rulebook (PMG24) says: “Companies must base their submission on the final SmPC… as approved by the licensing authority.” So when they say NWBO isn’t yet in a position to submit, they’re not warning you. They’re giving you a process signal: 🧩 They don’t have the final label yet ✅ And that only happens after approval is internally granted 🔁 6️⃣ The Only Logical Phase Left Is Labeling Match the facts: •“Fully engaged” = real-time MHRA interaction •7 months in = scientific review likely finished •“Not in position to submit” = waiting for SmPC •NICE can’t proceed = label must still be pending •No data requests, no deficiencies = nothing’s broken 📌 Which means: MHRA and NWBO are finalizing the label. Right now. 🎓 7️⃣ Here’s the Clean Analogy Think of MHRA like a university. NWBO submitted their thesis. The professors reviewed it. They said: “Congratulations…you passed!” Now they’re working on the diploma: what it should say, how it should be worded, and when it gets handed over. Until that’s done, NWBO can’t apply to NICE. They’re not rejected. They’re graduating. ✅ Final Takeaway This letter doesn’t signal delay. It signals positioning. If the July XX NICE letter is real, then: •✅ MHRA scientific review is complete •✅ Internal approval decision has been made •✅ The SmPC (label) is being finalized •✅ NICE is waiting for that label to unlock the next step •✅ NWBO is not stalled, they are engaged in the final step before public approval 🧠 It’s not a problem. 🔐 It’s the last gate. Disclaimer: This analysis assumes the July 15, 2025 NICE letter is authentic and reflects NWBO’s current status. It is speculative, not official, and does not constitute investment advice.  XXXXX engagements  **Related Topics** [regulatory](/topic/regulatory) [$nwbo](/topic/$nwbo) [Post Link](https://x.com/andrewcaravello/status/1945222957535551496)
[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]
Andrew Caravello, DO @andrewcaravello on x 1088 followers
Created: 2025-07-15 20:44:28 UTC
📄 Why the July XX NICE Letter Strongly Suggests $NWBO Is in the Final Step: Labeling
A step-by-step breakdown for those trying to decode the regulatory silence
Let’s walk through what the July XX NICE letter actually says, what it doesn’t say, and why all roads point to one conclusion: MHRA labeling is happening right now.
1️⃣ What the Letter Says
“NWBO is still fully occupied and engaged in the Marketing Authorisation Application (MAA) process with the MHRA.”
“The company is not yet in a position to provide their evidence submission…”
This tells us two things:
✔️ NWBO is still in active dialogue with the MHRA ✔️ NWBO cannot proceed to the next step (NICE submission) yet
🚫 2️⃣ What It Doesn’t Say
It does not say: ✖️ MHRA requested more data ✖️ The company failed a review ✖️ The process is paused or delayed
If anything were wrong, the wording would flag that. Instead, we’re told they’re “fully engaged.” That’s a live channel, not a red flag.
⏱️ 3️⃣ Let’s Talk Timing
📅 MAA submitted: December 20, 2023 📅 NICE response: July 15, 2025
That’s X months later, and most MHRA scientific reviews are completed within 150–210 days. Which means: 💡 The scientific evaluation is almost certainly done.
📋 4️⃣ What Happens After Review?
The final stage is called labeling, technically known as finalizing the SmPC (Summary of Product Characteristics).
This is the regulatory instruction sheet. It defines: 🧬 What the product is approved for 💉 How it’s used 👥 Who it’s for ⚠️ Warnings and limitations
This phase is not public, but it’s busy. And it happens only after MHRA has internally said “yes.”
🧷 5️⃣ Why the “Not Yet in a Position” Line Confirms It
NICE doesn’t accept a submission unless the final label has been issued. Their rulebook (PMG24) says:
“Companies must base their submission on the final SmPC… as approved by the licensing authority.”
So when they say NWBO isn’t yet in a position to submit, they’re not warning you. They’re giving you a process signal:
🧩 They don’t have the final label yet ✅ And that only happens after approval is internally granted
🔁 6️⃣ The Only Logical Phase Left Is Labeling
Match the facts: •“Fully engaged” = real-time MHRA interaction •7 months in = scientific review likely finished •“Not in position to submit” = waiting for SmPC •NICE can’t proceed = label must still be pending •No data requests, no deficiencies = nothing’s broken
📌 Which means:
MHRA and NWBO are finalizing the label. Right now.
🎓 7️⃣ Here’s the Clean Analogy
Think of MHRA like a university.
NWBO submitted their thesis. The professors reviewed it. They said: “Congratulations…you passed!” Now they’re working on the diploma: what it should say, how it should be worded, and when it gets handed over.
Until that’s done, NWBO can’t apply to NICE. They’re not rejected. They’re graduating.
✅ Final Takeaway
This letter doesn’t signal delay. It signals positioning.
If the July XX NICE letter is real, then: •✅ MHRA scientific review is complete •✅ Internal approval decision has been made •✅ The SmPC (label) is being finalized •✅ NICE is waiting for that label to unlock the next step •✅ NWBO is not stalled, they are engaged in the final step before public approval
🧠 It’s not a problem. 🔐 It’s the last gate.
Disclaimer: This analysis assumes the July 15, 2025 NICE letter is authentic and reflects NWBO’s current status. It is speculative, not official, and does not constitute investment advice.
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Related Topics regulatory $nwbo