Member Info for backinblak

BE- I agree on the potential partner - one would like to see something done in that regard by Christmas - could go longer though and still be progressing. Even if progress was slow as long as its not a 'no deal' situation it would suffice.
if the partner that they are prioritizing is focused on US market then they will want agreements sooner as that path forward is known, I believe there is more time to play with for EMA approval - so that commercial partner is not under as much pressure.

On the FDA or EMA. I honestly don't expect the FDA minutes to have any impact - they have more or less told us the structure of the trial so the minutes will only confirm what we know. As for the EMA - I wouldn't hold my breadth - maybe we get some questions back by then but depending on NB it could also be March 21.

Ody -Not looking good for your 13 now. I have to say I thought you would probably get it but this RNS puts an end to any drift downwards - the trajectory will be upwards while people start to get FOMO. And for good reason, if this does get a commercial partner which as they say is promising then I do believe we are moving to 50+p. I haven't been too far wrong so far although I did expect this to rest at ~20p while we awaited this news. Even discounting that - the fact that the US trial is as basic as could be given what we already knew the price should be resting at mid 20's - add in commercial and well above that.

Ody - greed to get the best deal is not always the wise move- you agreed this would go up but wanted a better price - my advice - buy in today before the crowd comes

fantastic rns , couldnt possibly expect a better one at this point in time. Us trial is as basic as it could possibly be and commercial negotiations looking good.

In other words ody you haven't a clue of the fair valuation for FUM, but you know the SP was once around 12p so you'd like it to go back to that to buy in again which is fair enough but please don't pretend to know so much more than you do.

Ody - I could debate a lot of items you have said in your last few posts and I do wonder why you are so worried for all us investors who know so little about he mechanism of action. I can only speak for myself but I know enough and I know there is a reason we're getting the easier regulatory route of being a medical device hence the attraction of this share. I believe most invested here also have enough of an understanding.

What I really want to know form you is the following. You have said you want to invest but you will only do so after dilution and you will pick your shares up at 12p or less (fair enough it might happen but maybe not). Converting the SP into MCap - 16p today equates to 39mil company valuation whereas at 12p the company is worth ~30mil. What calculations have you used to determine the company is only worth 30mil? Or do you think they will raise an additional 9 million. Basically what do you think the company is worth today as this tells us what the SP is and why do you give it that valuation?

Sorry meant EMA in previous post not FDA.
I think if EMA want a 6 month trial we'll be very unlucky if we can't combine it with the FDA request. Ot at least have 80% overlap hence not that much additional monies required.

OMG SOS - Another 3 weeks without news. You poor thing. How will you manage, maybe they release a little RNS for you to ask are you OK and tell you its all working well and you will make a fortune.
Honestly the patience on here is unbelievable, think about it you invested here because you believed the story so I would expect people to be willing to wait years if that's what it takes. If you don't believe just sell out and look for a gain some other place.

Put a new heading on this post as am answering the Italians question of a few days ago.
You asked about the device I'm involved in and its relative complexity. So it is a long term implant and is quite complex but there are a lot of predicates. I should emphasise as regards my recent experience it's not that they asked a lot of questions or the type of question but it was the fact they they asked some questions after 3-4 months which took 6 weeks to answer then a couple of more (unrelated to initial questions) maybe 8 weeks later again which again took about 6 weeks to turn around but the final nail in the coffin was that they asked for a test which took 8 months to answer at the very end. Complete incompetence and no fault of ours - it would be easy to accept the 8 months questions if they asked it after about 3 months. All that said we would expect a minimum of 12 months for FDA regardless of complexity.

The other point I was thinking of since then as long as we don't get a question that takes longer than 6 months to answer I would be happy!! If they also want a trial of 6 months it doesn't really add any significant costs - not saying it is preferable but I wouldn't be surprised if share price holds steady even with a request for a 6 month trial.

Of course I'd like they ask for 6 month trial immediately, rather than 10 months down the road :)

Ody - for once I agree with bulk of what you have said. EMA will be no sooner than Sep/Oct. I've been saying this all along - if we submitted in July then we would be at least 12 months waiting for approval. the FUM BOD are probably waiting for the first feedback from EMA to get a feel for how close or far they are from getting approval. I don't know who FUM use as their Notified Body (possibly BSI). But I work in Med devices and we had huge issues getting EMA approval through a notified body who gave the questions in a piece meal fashion whereby they asked questions after 3months then when those questions were answered they asked more and finally asked a question the necessitated 9 months of testing!!!! Nightmare stuff. The days of the EU being an easier route than the US are gone - I mean gone , since change from MDD to MDR.
As for the FDA - hopefully the requirements are bottomed out and funding avenue is sorted sooner rather than later.
I think where we differ is that at these prices I do think the market has priced all of the above in and there is a chance that a partner would stump up some money for the trials getting some marketing rights or share of profit in some form in return. Also I don't see the big player being a serious pharma such as Pfizer - the market as I see it for this product (assuming its OTC) is those who have mild issues or even those who have no issues with ED but just trying it to give that extra bit or spice things up. Imagine the size of that market!!!!

Could you imagine BE - Dragons Den lol - Heres a sample I want you to try out. Debra you might have to wait until you get home :)

Last time I posted here it was a bit of a rant about Ody. I'm laughing now for someone who acted all knowing in where the share price was going he didn't been realize that FUM had submitted dossier for the EU approval, then has the audacity in a later post to tell BE to "Read the RNS", and again is wrong and has to be corrected by Italian.

Anyway that asides I'm enjoying reading this board as a lot of sensible posters on either side of bull/bear debate giving us a reasonably balanced view of things.
Obviously Ody has a point that we may need money i.e. dilution but as I said before if he's wrong it will be too late to jump on board, if we get any sort of partner willing to pay for trials we will fly. I do worry that they seem to be waiting on EU feedback before raising money or progressing the US trial. That said the EU notified body could easily come back and ask for a similar trial which would give certainty to any potential partner and more importantly would mean that the US trial could be used to satisfy the EU requirements too (maybe with some small tweaks).
I believe for these reasons they won't go too far with US trial until they know what the EU want. My final thought is that we have possibly missed a trick in not doing a fundraise and dilution when share price was ~20p - Could have raised money at 18p and then we could play hard ball with any partners.
Someone also said this is a low risk (relative for AIM) and I'm inclined to agree, we will get approval one way or the other and the price will be substantially up from where it is today - if you're willing not to sweat the peaks and troughs in between here and that day.

Dont understand why this isn't holding at a higher price. The last 3 months have put this company on solid footing and I know we want to get confirmation of handover and rate of coal extraction per month but I would have thought the price would be 0.06 or 0.07 while we wait for this news which is surely imminent.

All I wanted to see was that there is a number of commercial partners. I know its vague but its all you could give in these updates. Anything more solid than that will have to wait for a RNS. In all likelihood there won't be any commitment from a partner until they see what the FDA say.
There was never going to be a solid update on EU submission and they shouldn't have indicated that previously. I've said it all along these submissions take 12 months and we submitted in July. If BSI are the notified body I expect (and quite sure) they haven't even picked up the file yet.
As for the money situation and needing cash for trials this was already know or should be known by all investors the key questions is does a commercial partner provide the cash. If commercial partner then SP shoots up and Ody and co who are waiting for dilution loose out on potential gains. Of course it may be a dilution in which event we all have to wait longer to make our profits but we WILL make them but could have made more if we applied Ody's tactics.
I'm happy to wait as the Ody route while very logical is also higher risk in my opinion than buying in now at anything below 20.
Lets hope potential partners become actual partners.

Im delighted to accept this prestigious accolade of behalf of all my supporters. Im even more happy that we all agreed to wager £100 each for the winners pot.
To win this outright im going to estimate that the next rns is going to happen on October 5th and i feel it will be very positive re the finance, ?? .
Any father ted fans should youtube 'father ted acceptance speech'

Possibly an II? Someone certainly has the opposite approach to ody, they re not sitting on the sidelines waiting for this to do share issue before buying in. Obvthink there will be good news soon.

BTW your post has nothing in it that everyone of doesn't already know. Of course there could be a rights issue to pay for a 6 month trial and that will decrease the Sp, if there was no chance of that the SP would be 50p now, thats so obviousits not worth saying. As for revenue not covering it, well not sure what you're talking about on that front., i would say thats a given.
The reason people are holding is that theres also a good chance that they strike a commercial deal with someone who pays for the trial and hey presto we jump back to the twenties and beyomd in one day.

You're so clever ody, i wish i was as clever as you with your degrees and all knowing wisdom of the exact share price movements.
Do you realise how much of a knob you have sounded since you came on this board. If not please just re read your posts.
Sorry but someone has to say it.

Getting closer to that 100mil market cap. Steady as she goes.
The most relaxing share to be bought into. :)

Thanks Shezer, going away from percentages i thought NSCI owned just over a million shares so theese additional 236k shares makes that 1.24mill shares of PDSB? thats approximately 2.5mil pounds worth. Am I correct ?

folks, just doing a little research on this company. Am i right in saying that since PDSB did their rights issue that NSCI's holding has gone from 7% odd to about 4.5%? I ddint really see any market cap decrease here (This consolidation asides).