Member Info for jam2morrow

Blimey, that was a bit of a damp squib today, I thought we'd hold 70p, but under 60 ? Looks like the market feels sales will be tough. I wonder if any of the big holders feel this as well and have adjusted their positions ? Something like 5% of shares changing hands; I don't think we'll see any TR1s though.
If this level of share price stays for long then there must be the chance of a low - ball offer surely ?

type 2 is a more involved examination - takes 6 mths. This took us in theory to 30th september.
type 1, less procedure, normally 3 months. I guess when the new information was submitted then the 3 month extension meant we became type 1, a more straightforward appraisal.
Thanks to the internet searchers today.....looks good

Anybody know how the FDA communication is conveyed ? I mean, if approval comes in the form of a physical 'letter', then may be received after 30th ? I had assumed they'd want this off the desk before Xmas but who knows ?
CRL is Complete Response Letter or is that just a figurative term ? So many questions !

a small top up for me, rude not to really.
We may get a similar pattern tomorrow if no RNS

@Lincolnite....difficult to believe another CRL and 12 more months.....but given the price we are, looks like the market still has it as a possibility (unless it thinks approval is not going to be a big deal, pricewise).
Is there no middle way ? approval with unexpected conditions ? has to be monitored in some way before full approval, and full sales of the product can be given go-ahead ? Hope not but who knows ?
Always smart to consider all the scenarios and how they play out

don't think a stop loss would trigger properly on these smaller aim shares. It could even be harmful. This is just my opinion but for example the september RNS when we were told 3 month delay.....say u had a stop loss of 50p.....the price drops straight away to sub 40p and probably ur broker can only sell at this price.....then u get a traders bounce back up to high 40s but ur stop loss has triggered and u get auction price only.
Just my opinion......others may have more experience with stop losses on AIM

https://numbers.otc.duke.edu/2018-report/2018/08/27/polarean-clinical-trials/

polarean enrolled first trial patients thru UVA - university of virginia hospital.
your link suggests FDA could approve technique in 'coming year'. We want it this year ! all be it might be the last days of this year

thnx @Duly red, i've missed that, i'm counting 90 days from 30th september. 30th dec is a friday, so ok its possible FDA will be working thru that week.
If you want to be in for a decision, you've got to be in pdq

a few buys coming in mid morning, but the volumes are tiny really. There is a good chance that FDA will want this cleared before xmas hols.....Has anyone worked out which date the 90 day extension takes us to ?......29th December ?

how does 'Andrada' reflecct expanding Lithium and tantalum resource ?..........Litantula maybe....... may as well have 'under-radar' than proposed name !

deffo under the radar @trunky.....15 trades today, and most of them sells.
How much downside risk is there ? Its a medical device, not a new drug.....they've gotta let it go sooner or later. Personally, I think the market is not pricing in too much upside, pricewise, with approval; we'll see. I'll be disappointed if it doesn't get over a £ tho'

the market has called this pretty well since the first FDA submission; the price we are at the moment suggests maybe 80p on approval ? Since the get go, 2 questions:
What are the chances of approval at or B4 next deadline ?
How much is this company worth with full FDA approval ?

Not sure i'd translate ''the required information would constitute a major amendment to the New Drug Application'' as dotting i's and crossing t's ......and we still have persistent sellers here.
I do think that FDA will want to get this off the desk before Xmas tho
GL patient holders

thnx deepjoy........are u all out of polx now ? they got the 90 days pretty quick so either they worked double fast or the required info wasn't too onerous......most people sitting tight i think

This is why I struggle to understand how a big trade like yesterdays 1.7 M happens. I think it was poster deepjoy who explained that the order sits on the books until mm's have enough shares to cover it.....well if thats true with these 'tiny' volumes it must have been sitting there for a couple of weeks......before we got the 90 days.....which makes no sense.
I'm still inclined to think that large trades like this are arranged between two parties

good move today, but still sellers into the rises

i think on aim, major shareholders have to notify firstly if they cross the 3% holdings threshold and every subsequent 1% thereafter

Its annoying because there are many instances of gases being used in medical procedures......nitrous oxide inhaled as an anaesthetic....oxygen of course....I cant believe that this would be a completely new process for Linde.
FDA have intimated that the 'current good manufacturing process' needs to be altered in some way; that this alteration would constitute a major amendment to the NDA seems a bit strange to me, but to be fair, the required information was submitted in double quick time and suggests that all concerned are now more focused.
A fairly comfortable hold for me

good call for the 30th pj....I wasn't expecting this extension to come so soon
'FDA has suggested that required information would constitute a major amendment to the NDA'
''said information'' 'if timely submitted would allow FDA to allow 90 day extension'
So between the 22nd and today the manufacturing partner has managed to submit the information that would constitute a major amendment to the NDA.....maybe wasn't such a big deal then.....
This feels as tho its close to getting over the line
surprised we haven't seen a bit more bounce in sp today