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StonkMaster

03/10/26 10:43 AM

#817300 RE: underpar71 #817295

Agree. Overall actions and tone don't suggest a refusal.
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DrHigh

03/10/26 11:00 AM

#817304 RE: underpar71 #817295

the "she was excited/giddy/upbeat pump has been used every year for the last 5 years.

they told us 4 months ago that construction had begun. then told us months later that construction was set to begin. These people lie almost as often as they take a breath. bring on the 10Q where we can finally see what Advent is doing outside of NWBO.
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zugzwang

03/10/26 1:02 PM

#817333 RE: underpar71 #817295

I specifically asked, does LP consider it a material event if there was a CHM referral for denial back to the MHRA? I was not given a straight answer. "I'm not involved on the regulatory side." I was told we are not the only MAA waiting 2+ years.



Interesting response from the company.
I assume it came from Zavoico.

Regarding involvement on the regulatory side, I wonder who is involved - is it just LP?
Does anyone at NWBO besides LP have access to the portal where the MAA status can be checked?
Does "not involved on the regulatory side" include not knowing whether a CHM negative opinion is being appealed?
An appeal can of course involve active dialog between the MHRA and the company, so saying they are actively engaged is not inaccurate.

Also "not the only MAA waiting 2+ years" does not square with the MHRA saying there is no backlog, unless those others are also in the same grey zone as NWBO.

The information vacuum only encourages baseless speculation from all sides. Overall, very frustrating.