Member Info for Mills240

Day 184 total (and Day 92 since the clarification), the statistics shift in a way that is actually counter-intuitive: a longer wait often correlates with a "Yes."

Silence is Golden 🤞😂

Day 92-93 since the extra info was supplied 😉

When an application rolls into Day 91, Day 92, or Day 95, it is almost always for one of two "positive" reasons:

​The "Orphan Subset" Negotiation: The FDA agrees the drug should be granted ODD, but they are internally debating the exact wording of the "subset" (e.g., "Idiopathic Pulmonary Fibrosis" vs. a more specific sub-type).

​The Signature Queue: The Office of Orphan Products Development is notorious for "batching" approvals.

Halifax share account reporting 1.05 for the Sp ... 🤞🤞

LT, 💯 Historically, if a company hasn't heard a "No" by day 80, the odds of a "Yes" increase, as the delay often involves the FDA's legal team refining the specific wording of the designation.

Day 89 .

Tuesday = 90 days 🚀

Just shows RNS can drop at anytime ...

The "Secondary Window": It has been roughly 85 days since the FDA requested clarification (November 12, 2025).

Historically, when a drug receives ODD in Europe for a condition like IPF, the FDA grants it in the US over 85 -90 % of the time.

Yesterday RNS didn't include a "Material Uncertainty" warning. By omitting it, the directors are legally attesting that they have enough capital to last through at least February 2027 without an emergency injection

Unfortunately this isnt the news NCF wants to read. 😂

Curly... funny how you haven't posted since August

since this little gem "Here comes the raise at what price?????"

what happened days later we hit 0.45 and 53%🤣👌

Lets see what happens of the 12th February 👍

Makes no difference aim or lse , still believe the auditors would have requested the funding statement

Typo £93K

On their current cash burn the £94K = 7.6 weeks ..

will funding be needed or was th3 statement added to please auditors ?

That's even if a raise will actually be required if FDA and partnership arrives in the next 4 -8 weeks...(£93K in bank).

The mention of funding would of be at the request of the auditors, to meet AIM Rules & Regulation..

Not as bas as Bushveld Minerals 🤣🤣👌

Strengthening the "Hand" in Licensing Talks

​Negotiation Leverage: If NFX has only £100k in the bank, a Big Pharma company knows they are desperate and will offer a low-ball licensing deal.

​The "War Chest": By mentioning a further raise, NFX is telling potential partners: "We have the funds to walk away from a bad deal and continue developing this ourselves if we have to." A stronger balance sheet usually leads to a higher upfront payment in a licensing deal.

Probability of Receiving Orphan Drug Designation (The Current Goal)

​Estimated Probability: 75% – 85%

​Why so high? Nuformix already received ODD for NXP002 from the European Medicines Agency (EMA) in May 2025. Historical data shows a 90%+ agreement rate between the EMA and FDA for these designations.

💦

Sony LinkBuds Clip (WF-LC900) release today.

Sony WF-1000XM6 expected release date 12th February

The official blueprints and internal layout for the Sony YY2985 (the upcoming WF-1000XM6) were revealed through its FCC (Federal Communications Commission) certification filings. Because these are regulatory documents, they provide the most accurate look at the hardware architecture before the official retail launch.