Member Info for LTbeliever

Clock stops..then restarts when response is received. 1 week ago (last RNS) we were already quite close to the 90 days so not much left on the clock IMO; specific query and readily available data means a quick resolution of the FDA's request.

That's another 60k from those delayed morning trades; is someone really spending so much money on a gut feeling? Time will tell.

FWIW, if you check the last trades y'day after the 1 share UT @0.25 at market close, there are some more buys totaling appx GBP65.000!

The SP started moving upwards, quickly, on initially low volumes y'day afternoon; IMO, the MMaker knew/realised that a big buyer was behind those trades hence the steep rise - on zero news - within a couple of hours; given the lack of news as we speak, it's quite probable that this buyer will continue buying this afternoon - irrespective of US Markets' trajectory.

And I have repeated earlier that should AI, Nvidia, Bitcoin etc drop another 10-15% it may not be bad for Biotech/healthcare stocks as money can rotate into this sector (sooner or later).

Anybody knows if the FDA releases its decision early morning (US time), or it's made public only after the applicant is informed first (eg by email?).

The EMA one was announced by NFX at 7am RNS, but as Soup says, the EMA and FDA work differently.

It seems our "mystery" buyer from y'day operates in the afternoon (US trading hours) and actually started buying when the US markets were crashing - so we have a determined buyer; let's see if they show up later today.

0.37 hit, 0.356 Bid

About time! At least it shows that there is sufficient cash & potential to have/justify a bigger payroll. Helping clients utilise the equipment more is a good idea, and doesn't cost much.

I am sure there will many people happy to buy 1st thing tmrow @ 0.26!

Exciting afternoon, let's see what tomorrow has in store.

0.335-0.35

Maybe news from the US, being processed into a morning RNS? Just speculating!

IMHO, a successful ODD designation by the FDA is tied to / will lead to a collaboration deal ("discussed" for over 2 years), hence why - possibly - the SP rises as this designation approaches; it basically opens many doors and/or is a final prerequisite before a deal closes (that some people may be aware of?).

As I said...SP to rise before any RNS drops :)

B_Positive, good Targets! Any numbers to share, which form the basis of your estimates?

Soup, I am not sure that any EMA questions would have been cleared in the pre-submission phase, which started around the 13 jan 2025? It was just 2 weeks before the official submission on 28 Jan, how could possibly EMA clear all queries in a 2-week period before even reviewing the data/docs etc? And if they cleared everything by the 28 Jan, what's the point of the following 3 months? I agree that the process differs from the FDA's one but IMO queries came during the 3 month review period and were promptly dealt with; and this why I think the Co has already submitted its response to the FDA; but, nobody is certain so we have to wait a few more days; the SP will move first IMO (i.e. before an RNS).

Just for info, re the EU ODD application, NFX made the application (announced it) on 28 Jan and approval announced on 30 April; so, just over 3 months and nothing announced in between about any delays due to requested clarifications re the submission; IMO, as a lot more rests on the FDA approval (possibly, tied to collaboration deals?) NFX felt compelled to release an RNS about the delay even if this relates to 1-2 weeks longer past the 3 months' deadline.

Soup, IMO, the Co must have already responded; the RNS said "Company will submit a response to the FDA as soon as possible using existing data and information in the Company's possession"; remember that the RNS was issued - very likely - a few days after the FDA's request and the Co would not have released it saying "asap" unless they already had a good idea about when they could respond - IMO.

Yes, we know the undervaluation and potential, just need the right news to push it out of this 0.04-0.05 range.

Friday was a bad day for UK and US (during market trading hours) so yes, some negative overreaction possibly; SP had dropped 20% on just the FDA's decision delay (by 1-2 weeks) so this'd indicate that there'll be a positive reaction when we finally hear about the US ODD status.