Roundtable Discussion; The Future of Mineral Sands. Watch the video here.
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Too true.People who use fake words to pretend they know truth are fake sellers. Postulate & fallacous made up words to make him sound clever. Ignore. The truth will come out.
For Goodness sake people ignore Bald Eagle ! Only appears when it thinks of a negative spin to apply to any topic. Responding merely gives it an opportunity.
"Unfortunate turn of phrase!"
==============================
Nothing wrong with a bit of slippage...as long as one follows government advice!!
Unfortunate turn of phrase!
Slippage in current environment is to be expected.
bald eagle I've just listened to those very words. nothing new there. just stating the obvious.if it were certain the world and his dog would be in here.you' re correct .the slide does say july. only an estimate of course,so ill be happy if we have news during august.usually some slippage with these things.
"....We have some ongoing discussion with them on whether our clinical data package as is – using some of the comparisons with data in the literature – will be sufficient. They were very receptive to the arguments that we were making and they have asked us to provide them more detail on that. We are putting that data package together and usually within 2 to 3 months the FDA will grant a meeting. They have actually asked us for another meeting to discuss the clinical sufficiency and provided that goes well – there is always an element of doubt when you are dealing with a regulatory authority – we anticipate filing in the US around September this year..."
Taken from Ken James presentation on 1st April 2020 (All Fools' day!!)
ok bald eagle i didn't look at the slides,but will do so when i get a minute.agree with the need not to take things at face value.well aware if it.ive done this many times.no such thing as a free lunch.
theItalian, it's not what he says...it's the information contained in the presentation slide.
Sometimes one has to 'almost' ignore what they are saying and look a little deeper!! Not on this particular point but with FUM in general (& other companies). Just like politicians they will want to put a positive spin on the data...ignore the less attractive stuff and concentrate on what makes them look good. Unfortunately when in a negotiation with potential partners (who emply 'real' experts) they will be doing just that...looking for the 'bad' stuff and bear traps....ignoring the 'aren't we wonderful' carp...looking at the actual data!!
Not in this case 'perhaps'....although did he mention the FDA data sufficiency test & if he thought FUM would pass it (easily!!)?
bald eagle my apologies, at least for using the word" fixed,"which you did not. i was reading something that was not there. however I've listened again to the james presentation at the period you quote and unless my hearings is as bad as my eyesight, he does not say it it was estimated take place in july. he talks about the request for an additional meeting and then says words to the effect that if all goes well they would expec to file in september.no mention of july as such.unless I've missed it.anyway clearly it should take place in july or august at some point so not really much point worrying about it till we hear. yes of course it fum need additional data for fda it will be a hurdle they will have to overcome,.they have been completely transparent regarding this possibility (the same possibility exists relation to the EMA application although fum seem to regard this as less likely). that's just the risk you run with this type of thing. if they announce the fda need additional data the s/p will probably take a hit,just as it will probably be boosted if they announce no additional data is required. hopefully all current and potential investors realise this. if they do find that additional data is required for fda but say not for EMA they might well decide to run with the EMA first and get one approval under the beltas it were, but we are now going onto the realm of pure speculation ,so I'm comfortable with just waitingto see what happens.
theItalian, if the FDA did require additional information then potentially it could be a bit of a blow to FUM. At best it would cause additional delay...worse would be need for a rights issue to fund the extra work....or they might just delay US approval and concentrate on EU approval (which doesn't appear to have the same 'data' hurdle to traverse).
Of course, even if the meeting is in July, FUM might not get the decision from the FDA (whether they do need extra info) straight away. So an RNS in August could be quite possible.
theItalian, I never said it was fixed....I said it was due. As I said in my post it may well have been delayed because of the pandemic. I got my information from the presentation Ken James did on 1st April 2020. It was 'estimated' to take place in July 2020.
If the meeting is delayed (probably to be expected) then this will have an impact on when they submit the dossier...which was 'estimated' for Sept 2020.
Relevant screenshot at circa 28 minutes into the webcast. It might be out of date by now....but if they have managed to keep to the timeline then meeting is a matter of weeks away.
bald eagle i don't disagree with your post in principle but i don't think we have been told that the meeting is fixed for July..the last t/u simply said a date had been fixed. can you reference where it says that the date is in july.f rom borders last interview the only specific things for july are submission of the ema package and cbd collab update. if I've missed something and you can reference it fine, but otherwise inmnot expecting anything on FDA in july.i suspect there is a bit of a lead in time to the meeting so my guess,and it,s just that, isprobably mid august for the meeting.i have always accepted that further data may be required for US,although hopefully it won't.
The 2nd meeting with the FDA is due to take place in July (unless delayed because of the Coronavirus pandemic of course).. The purpose of this meeting is to review FM57 clinical study report (CSR) to determine data sufficiency. It is important - for FUM - that the FDA is 'happy' with the data in FM57. If additional information is required this could delay the US submission of the de novo request dossier...scheduled for Sept 2020. Worse case scenario is that FDA require something akin to an expensive clinical study...which would 'presumably' require FUM to seek additional funds (or delay the FDA submission).