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Investor082

12/30/25 5:45 AM

#805402 RE: HyGro #805378

Couldn’t agree more. LP’s financiers and shorts will have an extended party in 2026 and 2027 until they run out of shares again.

She has already broadcasted that NICE reimbursement is unlikely in 2026. In fact, they wont even submit evidence. Otherwise they have submitted a while back so that both NICE and MHRA approvals were more or less simultaneous.

Talking about compassionate use of L in US and pivoting towards Direct and in licensed Roswell trial tells you that they don’t plan on submitting to FDA anytime soon. Certainly not in 2026.

LP keeps on giving to her financiers and shorts. They can’t wait. Easy money! ;)
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SkyLimit2022

12/30/25 11:23 AM

#805477 RE: HyGro #805378

Gro,

Thanks for the reply 😶



I didn’t say that U.K. approval would “have bearing” on a decision by FDA, but I’m glad you raised that topic…

It is a noteworthy fact that 🇺🇸FDA chose to partner with 🇬🇧MHRA for Orbis & MHRA’s MAA decision is certainly relevant & will have global significance. The U.K. is a member nation of Orbis & approval would bode well for applications in other member nations. We all know that a BLA in the U.S. is the starting point for Orbis, but an initial approval in another country is still meaningful & important.

Aside from that, what I actually said in my reply to you was this: While the MAA review has been ongoing for 2 years, NWBO’s position is becoming more & more favorable in the U.S. because…

✅️ EDEN & Grade C capacity is advancing
✅️ U.S. regulatory environment is advancing
✅️ Other products are also advancing (Direct & aDC1)

Factors such as compassionate use patients & approval in other nations are not central to FDA’s review process, but they are unquestionably relevant.

Fud Flood 🌊
Bullish
Bullish