Member Info for Soupdragon78

LT, with the EMA there is a pre-submission phase where the company submits a draft and has a specific meeting with the EMA, this is the point in time where queries are usually fielded by the EMA, hence no delay during the process.

The FDA works differently, they do not meet nor advice companies on their submissions beforehand, hence they stop the clock when they raise queries during the process, but there is a greater likelyhood of questions as they have not vetted the submission beforehand.

Personally I doubt NFX has submitted a response yet, the submission documents are pulled together by external consultants and then it goes through a US based agent who is the person who actually submits (the FDA does not accept submissions for non-native companies so NFX have to use an agent).

Fair enough OSD, I missed the 'being able to...' bit, understand your sentiments, but always err on the side of caution with NFX timelines.

Typo… that should have read I wouldn’t be so free as to say they would ‘respond immediately’

Yes they may have the data, but we don’t know what they will need to do to present it in the right way.

Osd, I would be so free to say they will ‘respond immediately’

Highly likely that the EMA request was made during the pre-submission phase before the EMA application went in. Hence no rns required.

Goup, the FDA submission is a series of forms, so you only provide the information required to suit those.

Secondly the RNS says that the information requested is ‘similar’ to that previously requested by the EMA and that they have the data.

So, note it’s not an exact match for info requested previously, but there are similarities, so they will have to check the data and present it in a specific way that would suit the FDA request.

LT the question is really about how relevant those broker notes are to the company now.

There has been a large shift in the approach taken by the company to the positioning of nxp002, particularly as it will be used as a combination therapy. This will have an impact on the value of potential licensing deals.

Its pro-rata as explained in the RNS, so its proportionate to your overall holding.

'Excess Application Facility will be scaled back on a pro-rata basis, with the same scaling methodology'

Sazzle, it will take the remainder of the 90 days.

As I mentioned earlier, when the FDA issues a query, the 90 day review period stops at that point. The applicant then responds and when the response is received by the FDA the clock starts ticking again.

So if on day 80 the FDA issue a query, the clock stops at day 80. The applicant responds and the FDA receives it... they now have 10 days remaining.

It could be that the FDA issued the query on day 88 or 89, meaning once they receive a response they have to finish the review in 1 or 2 days.

Profit, you had no clue about the fda delay so can take no credit for the sp action.

It’s dropped for reasons you were not predicting.

If anyone was wanting a quick profit from their placing shares they would have done so at 0.5p

Furthermore, all this means is that the 90 day period is on hold until the additional info is received.

For example if it was on day 80 that the FDA decide to request the info, then the clock stops at 80 days, and restarts once the info is received. So then they have 10 days left to close the review.

So for NFX depending on when the request came through, I’m assuming in the last week or so, it means a quick turn around once they’ve sent it through.

Zeeco, it’s not incompetence or an error.

The FDA ODD is a form submission with limited scope. You submit exactly what they ask you to submit, not every single other thing that you have available.

The ODD is related more to its use in a disease than the performance of the drug, so you don’t supply all of the performance data.

Don’t be surprised if there’s no FDA news this week. Remember it’s 90 days from receipt.

We know when they submitted but we don’t know the date of validation.

I think people won’t find out how many they’ve got till the 13th.

Your broker will take the full amount from your account then reimburse for any difference.

Back in 2019 there were a few different things in play that pushed the shareprice up to its relative highs.

Firstly looking at the share in issue, back then there were circa 470m shares in issue with large chunks held by Spreadex and CPI. Albeit those were being sold off intermittently. Once we have had the open offer shares admitted to market next week there will be 2,109,749,903 NFX shares in issue.

Obviously this then determines the MCAP. So back in 2019 when the sp spiked just shy of 15p, this gave an mcap at the time of circa £70m.

So for with our enlarged share capital after next weeks open offer, if NFX got back to a £70m MCAP, then the shareprice would sit at around 3.3p which is not too bad at just under 10 times the current sp.

Looking at the news / rumours etc that caused the spike back in 2019.

NXP001 was still wholly owned by the company and yet to hit the rocks with the Chinese partner, so there was some optimism that it would go into phase 1 trials.

Then there was the cannabinoid deal with Ebers Tech which was set up by then chairman Dave Tapolczay. (strangely Ebers was only incorporated the day before the deal was announced). At the time cannabinoids were the trend in the market so that ticked a lot of boxes for traders and led to the first wave up towards 14p.

Then there was a 'leak' of outlicencing in the Sunday Times, which name Kissei as a potential suitor for NXP002, this led to the second wave up to 15p.

This rumour wasn't welcomes as it caused a lot of problems between Kissei (who invented Tranilast) and NFX, causing that relationship to break down. It wasn't further helped by one of the NFX directors at the time selling all their shares the week after the rumour appeared in the press.

With these as the basis of the shareprice highs back in 2019, as you say OSD, what would be the precursor of a similar thing happening now.

As mentioned, to hit the same MCAP as back then we would reach 3.3p per share which is commendable, but to reach 15p this would value NFX at circa £315m which even with a deal would be a big ask.

Looking back at RedX when they outlicenced to AZ for i think £17m upfront and a few hundred million in milestones, their MCAP never got past the £175m mark and they had many other pipeline drugs.

Nowadays as Dan says, IPF drugs are focussing on being combination therapies not stand alone, so won't command such big deals. So we will have to see where that goes.

Thank you Transhaven for the sentiment, whilst I am spikey in posting sometimes its not from a point of malice (probably more from frustration) and wish the best for each poster.

I have my thoughts on what may be happening in the background in the south Cambridge area so will have to see if they come to fruition.

Meaning the P&D turtles by the way.

Lose the first 'it' from 'bit itchy' and you've hit the nail.

If you're here for the FDA and any subsequent deal you won't be bothered by what the bids doing on a momentary basis.