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Kdonkey. apologies predictive text
donkey think it has to be class 2.the de novo process is to determine what class it gets (1 or 2) rather than being automatically classed as 3.as they haven't gone for class 1 in ema, i assume they are aiming for class2 in US. perhaps other posters can point to something more definite.
the.italian - that is a great article...not any easy read, but thanks for sharing that.....
Do we know the class of device MED is going to be, as that seem the deciding factor on a trial or not, for the EMA. Also the FDA device 6 month test isn't going to be anywhere near as tough as Phase III...just a shame it's for 6 months .
well thats my take BE.in the initial RNS of 20th dec they say"although small studies may be require,especially the case of the US". this theme was ,i am sure,repeated in later announcements although i have not checked today(time had been at a premium today).if you have not done so yet you really should read the link below as it really does give a good perspective on matters and is something of substance as opposed to all the personal speculation (including that from me)
theItalian, thank you for your thoughtful response.
I was not aware that FUM had suggested that the FDA were more likely to require additional data than EMA. If that is the case then it would be encouraging for investors. I do know that FUM have sought specialist advice for the EMA submission (& presumably likewise for FDA)....so it is possible that their consultant gave then confidence in the technical data they submitted to EMA would pass inspection. However they wouldn't have been able to give a cast iron guarantee...unless it was 'almost' a guarantee!!!
Ultimately we will have to wait for the fat lady to sing...but enough about Amanda.
theItalian, thank you for your thoughtful response.
I was not aware that FUM had suggested that the FDA were more likely to require additional data than EMA. If that is the case then it would be encouraging for investors. I do know that FUM have sought specialist advice for the EMA submission (& presumably likewise for FDA)....so it is possible that their consultant gave then confidence in the technical data they submitted to EMA.
bald eagle my take on the ema process is thiss.first none of us have any real idea whether ema will require more data, thats obvious. that said i think there are some grounds for modest optimism that they may not.i think i am correct in saying that it has always been expressly contemplated by fum (always meaning since the start of the new MED3000 process) that a further date/trial was possible for FDA process.whilst not ruling out the same for EMA, fum have never suggested it was likely in the same way as they did expresslyfor FDA.now i know some people take the view that you get radically different guidance from the 2 authorities, but quite frankly i think that is just wrong.yes the procedures are different, but i have never accepted that fum would not have been give the fullest possible guidance for the ema submission.what the guidance cannot do entirely is to cover questions arising from the full data package once it has been submitted and considered.hence the possibility of further data/trial being required and it cannot be ruled out.however given the different assessments of initial requirements by fum my take is that they feel there is a reasonable chance of further data /trial not being required for ema and that this is based on the EMA pre submission discussions. anyone thinking of investing now should,imo,consider the possibility that further data may be required, but they would have to balance that against the risk that if they leave it to see what is required, they will pretty certainly be facing a higher (perhaps significantly higher buy in price if nothing further is required. also just on todays RNS, i agree with the comments by some that the QSM audit is something you would expect them to achieve (i expect the standards are quite high for a medical device but it is fums specialist area) so its a modest piece of positive news and another step in the right direction. what is interesting is the comments about specialist advisor etc. of course it could be a mere puff, but I'm prepared to give them the benefit of the doubt. the was no need (and indeed it might have been inappropriate )to mention it unless it indicated positive change to the pre-existing situation,so again i regard it as a modest (perhaps more than modest )indication of positive developments in the potential commercialisation field.just my opinion of course.
Ody, your new prediction has changed from sub-10p to 14-18p. You have also stated your desire to buy in at sub-10p. As you now don't believe it will drop to that level, I presume you have decided not to invest in FUM*, so you might as well take your useless predictions and go and impress other boards with your scientific expertise and investment skills.
*Apart from your previous holding when you were a student all those years ago.
I very doubt its a case that "JB now understands that FUM would benefit from support in this area" regarding appointing specialist advisors to support commercial negotiations. God almighty. He hasn't been living in a cave or just joined FUM after working in a slaughterhouse for 20 years. I expect its much more likely to be case that its because its now an absolute necessity due to interest and discussions with interested parties. Not doubt about it. Very confident I will be proven correct here, and sooner than most will be expecting.
Ody,
I said mid twenties that’s correct.My 2 weeks are not up yet.When I posted 2 weeks ago it was at 15p.
When you have a decent amount of shares a penny increase is a lot.So mid twenties by the end of my 2weeks is a decent climb.
Then when it finally takes off it will hit the £ then we just have to see what individuals do with their shares as depends what shareholders want as a profit.
Jonah. You said share price in the midtwenties. It has barely changed. So. Here is my prediction.
The SP went up this morning on some basic good news. And people bought on back of that. But it is just the basics - "can FUM make this product in high enough quality". The answer was yes. It would have been a real surprise if it had failed.
Now the share price has fallen back because people realise this doesnt actual increase the chance of approval. Just that if it is approved, FUM have shown they make it to high enough quality.
Prediction: The share price will hover between 14 and 18p until any further news in September
Why was my 2 weeks the longest of all time?
You hate being proven wrong mr bald!!
"I you realising I was right with my 2 weeks."
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That 2 weeks is becoming the longest 2 weeks in the whole history of the universe. Are you working on Martian time?!
I do wish people would stop putting arbitary timescales on things...the SP will reach 108p on 1st APril....10-12p in September...whatever Jonah said 2 weeks ago (not sure of he did put a figure on it).
The SP will reach what it reaches, whan it reaches our targets we can buy/sell/whatever....although the Fibonacci crew may beg to differ.
"....and with potential now building, I struggle to see why we haven't seen more upwards movement on the SP"
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BoC, you really don't know?!
In 3-4 weeks we get the interim results. Which may or may not contain additional information on the requirements for the FDA 6 month trial. This may prompt some form of fund raising.
Also the EMA application requires the following: "Submission of Technical Documentation (TD) which includes sufficient efficacy, safety and quality data"
This seems very similar to the FDA 'data sufficiency' requirement. It wasn't something I was personally aware of until quite recently. It is the big hurdle they need to jump (IMO).
As I have mentioned before it would be good to know ASAP if EMA require additional data and they could incorporate any requirements into a joint EMA/FDA trial. Investors will be hoping that EMA will be 'happy' with the technical file as submitted (obviuously).
theItalian, what is your take on whether EMA will require addittional data like the FDA?
One positive from todays RNS. The EMA notified body is working despite the pandemic and replied to the QMS requirement quickly. Whether the technical requirement is as fast is unknown...hopefully yes!
Mr bald that’s the most sensible post you have ever made.
I you realising I was right with my 2 weeks.
Enjoy your rewards shareholders.
"The more significant bit in here for me, is the bit about FUM appointing specialist advisors to support commercial negotiations - should be music to our ears - JB now understands that FUM would benefit from support in this area"
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BoC, yes I agree. It was 'probably' more interesting that the main thrust of the RNS. It is difficult not to speculate what it could mean:
"Futura has now appointed specialised corporate advisers with international experience to facilitate commercial discussions with potential licensing and marketing partners."
It is 'probably' a realisation that Mr Barder needs specialist help to negotiate complex agreements with potential Pharma partners...as FUM have found in the past, a badly worded contract can store up problems for the future.
....and with potential now building, I struggle to see why we haven't seen more upwards movement on the SP
Once again, I find myself partially agreeing with Baldy on this one. Any company that can't set up and operate a quality management system (where there is good reason to do so) probably doesn't deserve to be in business. But it's a tick in the box. The more significant bit in here for me, is the bit about FUM appointing specialist advisors to support commercial negotiations - should be music to our ears - JB now understands that FUM would benefit from support in this area. It looks like they are doing all the right things in the right order - very encouraging!
KDonkey, it is an honest appraisal. The QMS part of the requirements was always going to be easier than the 'data sufficiency'...if you think otherwise then please explain why?
If they can get the 'data sufficiency' approved then that would be significant. But you seem to have a different opinion.
Are people really 'relieved' that FUM passed the QMS test....it should be a relatively simple thing to pass. All companies need some form of QMS nowadays. Do you really have such a low opinion of FUM's management that you thought they would fail? Even I knew they would pass QMS....'data sufficiency' is another matter!!
oh and no need to respond as I've just put on filter
OMG BE you really are depressing. I like that you question things, but the constant negativity is getting really tedious......every RNS you pour scorn.......you really should get out more and if you can't get a hooker....
If they could pass the QMS (Quality management) test then they really would be in trouble. I 'imagine' it is a paperwork exercise (much like ISO9001), which confirms they have procedures in place to manufacture a 'quality' product. Hopefully most companies have such procedures in place...and are following them.
The second part of the testin 'probably more tricky: "Submission of Technical Documentation (TD) which includes sufficient efficacy, safety and quality data"
If the EMA are 'happy' with the data sufficiency - unlike the FDA who requested an additional trial - then that would be a major achievement...and really warrant an RNS.
excellent news.