Member Info for jam2morrow

If they get a 90 day extension on Friday this will bounce right back.......but i'm not holding my breath for anything on Friday....ur 2 - 4 weeks would be good !

friday is the 30th ...the end of the current 6 month review period.....and perhaps the beginning of the 90day extension .....maybe PJ has inferred that 'a timely response' means by the 30th.....that wouldn't be my inference.....
without any definite information we can only guess

a 90 day extension to the timeline suggests 90 days added on from 30th sep.
Seems unlikely that the drug manufacturing partner will be able to supply said information by the 30th - particularly as FDA have 'suggested' that this information will constitute a major amendment to NDA.
What does a timely response mean in this context ?
Last weeks RNS was too vague.....needs clarification for patient shareholders.....hopefully something on Friday

@BBB They need to get the comms right now and start being a bit more transparent.
''The FDA has suggested that the required information would constitute a major amendment to the New Drug Application ("NDA") that, if timely submitted, would allow for the FDA to grant a 90-day extension to the review timeline. The FDA has proposed frequent meetings to occur during the extended review''.

The timelines become increasingly important now.
When will they timely submit ?
Does the 90 days start from this time ?
Have to say that the market has got this about right since the CRL. Lets hope that the market got the ''modest'' price drop right yesterday and this drug device will get clearance after this last hurdle
.

Re 200k bought/sold this afternoon.....and of course it has to be both.
Anybody understand how these trades work ? Looks to me as tho' this is an arranged transaction between 2 parties, hence no movement in price. I think if a buyer asks market to buy 200k then price has to move....but only guesswork on my part....clarification financial whizzes ?
Still pitiful volume , 200k or not !!

SP will normally revert to placing price of new issued shares. The tin price slump has scuppered us to some extent but really, if they can get revenue streams from all three minerals without having to 'borrow'/dilute any more, then things don't look too bad in my view. When u look at some of the other mining companies around that will have to borrow multiples of their Mcap to get to future production, then the grass would appear to be much greener here

when i post .......the market listens.....up 6% already !!

Mostly blue, but given where we are, the volume here is tiny. went to 62p when they re-submitted 5mths ago !
Come on investors.....get with the programme !
Always DYOR, ur investment could go down as well as up :-)

The announcement doesn't have to be on the exact date. In the case of IMM who, have received their response today, it was more than 2 weeks late . POLX have been very good at keeping things quiet; we still don't know exactly what the 'mainly' technical and manufacturing issues were.
Good luck holders.....but I would think luck is not needed here

Peters holds (held?) 81M , Whale holds(held?) 80.8M. New guys now hold 81M

@kaisersoze..... I was working on £1.20 and 90% chance of success......but seems the market does not agree on one, or both, of those figures ! At these levels has to be a good gamblers bet.
There was a large-ish sell today just before midday hasn't helped the price

here, price and volume wise, considering where we are on the timeline re decision.
Either I'm way too high on my price with approval (£1.20), or the market is giving this only about 50/50 chance of getting the approval and reaching that price.
Seems too cheap to me, maybe the general market is much more bearish than this time last year.

''Ongoing planning for a new clinical trial to seek FDA approval for label expansion into the high-value gas exchange applications of Polarean's technology''........high-value gas exchange applications ? large amounts of gas exchange like in an athlete ? or does high-value just mean $$ ?......I can't find any use of the phrase elsewhere

Thnx to Shandypants and Frozenassets for their links to IMM and the FDAs shifting of the expected deadline there. Seems like FDA is still under pressure and that this will go down to the deadline date or possibly beyond ?
The drop this am seems to being bought into. GL all

@ Sammy ''the CRL last year was essentially only manufacturing queries''
This is what we were told in the CRL last year : The FDA has determined it is unable to approve the NDA in its present form and has provided a list of issues to be addressed by the Company. These issues are mostly technical or manufacturing-related in nature and centre around the Xenon hyperpolariser system.
My reading of this is that they had a lot of issues last time. Now it may well be that they (FDA) were under pressure,they needed to inspect facilities/systems and didn't have time and used the CRL as a stall. We will probably never know
I expect u've seen the vid with Vadim Alexandre after the CRL. He says that we will know more clearly what the problems are in time. We don't. We have no more information than the first RNS. ''these issues are MOSTLY technical or manufacturing related.
The market is cautious here because we have very little info. I personally like the way the CEO has played it. The drug system is good, safe and a massive improvement on what iwas being used. We know that. Unfortunately that doesn't guarantee an FDA approval

Are what investors need to be asking themselves
What is this company worth with FDA approval ?
What are the chances of that approval being granted ?
Of course its not easy to put definite answers to those questions otherwise we'd see more buying here......looks like a good bet at these levels to me tho ......good luck holders.....soon gonna move......one way or the other !

I like the ticker ATM tho'.........ATM - a machine that dispenses cash........but lets not get too carried away......I'm still in the red here

The first to produce tho' @agricore ? I was in BCN(which was mooted to be the first) until it was bought out by Ganfeng. Theres also EMH, ZNWD, SAV, ALL, BHL listed on AIM and probably others i don't know about; but although they've been trading a while they are all a long way off production. The big producers: Ganfeng, Albermarle, SQM, Pilbara are listed elsewhere. I would have assumed some of the big London listed miners like Glencore, Rio or BHP produced at least some Lithium.....but perhaps not.
If ATM can actually manage production of Li in the timescales they are predicting, then it will really be quite remarkable

Agree @Shandy......I have posted that chance of failure here, second time round, is about 10%.......its pure guesswork but the company is not giving anything away as to the exact reason for the CRL. We can read between the lines and conclude it was a manufacturing issue (although, remember POLX RNSed issues, plural). It may be, also, as the Amatti guy says, that the FDA needs to pull its socks up a bit.....it may be that POLX took their eye off the ball with some of the processes.....we'll probably never know.
Lurking at the back of my cynical mind is big pharma loving this to fail again and pick it up cheap......the tech is good and its being used already .....so has to be a good bet.....maybe

So difficult to put any kind of measurement on this. The chances of any NDA succeeding are slim......80% or more will fail. If there were safety issues with using polarised xenon gas then this would not progress. I have assumed that FDA have issues with manufacturing process and these can be overcome.
There is risk here obviously but to measure how much risk without substantial inside knowledge is extreemly difficult to say. If anyone knows of a useful equivalent comparitor please post it :o)