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not sure how much relevance this will have in practice, but for those with time on their hands perhaps have a look at this. the marketing section(para 19 onwards )outlines the sort of advertising content and approaches which are not allowed etc,but it seems mostly the sensible precautionary stuff one would expect https://uk.practicallaw.thomsonreuters.com/2-618-6661?transitionType=Default&contextData=(sc.Default)&firstPage=true&bhcp=1#co_anchor_a477470

i have zero knowledge of the current music scene so probably shouldn't comment,but i do wonder if it's a genre thing. i know posters will say nelly is incredibly popular etc, but personally I'm hoping for a much wider range of artists than we have seen for the most part to date (with some notable exceptions,i do expect this from brixton when announced so await the details with interest.

oh volatility thank god for the correction i was just on the point of posting to say i didn't realise barder had an interest in sng. probably a good thing he hasn't, as if he hd he would probably not be focussed on FUM !. on a serious note it is a good thing he has an interest. one of the constant criticisms on MTFB was that the board held no shares at all.it was all explained away ostensibly plausibly as being an american style company and that was how they did things in US. nonesense of course,so good to know they have at least some skin in the game here.

yes thats my take as well Volatility.also on the point re viagra and generic market competitors, if we get OTC approval we will presumably be able to highlight the apparent advantages of MED 3000 over the others (e.g. speed of onset)and in this connection i have been looking at the lloyds pharmacy website for viagra and sildenafil and it states that both should be taken on an empty stomach.i did not know this, so presumably candlelight suppers are out for those users. another (perhaps very small) point of differentiation.

that is certainly the hope.fingers crossed!

very interesting question NoExcuses and that is hopefully to key to the next stage.only 2 countries apparently allow direct to consumer advertising for RX drugs , the US and New Zealand . so any advertising has so far been restricted to say professional publications and that type of thing. with oct there is clearly going to be more scope although no doubt there will be advertising and medical advisory standards to be met which will vary from country.I'm no expert here, but will be having a look into this. we have of course seen viagra advertised on Tv in UK . dont know about other countries but hopefully the scope will be much wider than at present.

ok bignose thanks for that.not sure about any FDA relaxation,but i do think the point about licensees is very interesting. with OTC it really is a different ball game i hope.certainly agree it should have a positive effect.operations update will be interesting.

been sitting down thinking this through,or trying to.are you thinking regent were hoping that if they got a favourable decision it would influence FDA treatment of their trial data or perhaps change the way the data was presented?something like that? if so thats perfectly possible i suppose although hard to see exactly how.im intrigued as to your take here.

morning lord font.thanks for your sage advice but unfortunately it fell literally on deaf ears, as i was already asleep (age you know), but very pleased to see posts this morning showing it went very well. onwards and upwards. still intrigued as to significance of 31st july though.

morning bignose.sorry but I'm struggling to follow you on this one.probably me just being more than usually dense but what strategic reason would there be to delay? perhaps you could kindly clarify.good to hear dr mike is assisting on EU.

Lofas apologies.predictive tet!

sofas could you elaborate please as i don't understand your post.have i missed something?

agreed bruce in principle,but all are inherently risky like all shares.i have been and still am an investor in PHD. it pays a dividend, or rather did until its s/p collapsed after a poor trading update a while ago.it makes a very respectable profit and is not in a speculative area (it provides systems for prompt/early settlement of customers invoices) but its comparatively small m/c made it vulnerable to the typical aim overreaction to bad news etc.not all aim shares are dogs but they do share the same kennel I'm afraid.in fairness one of PHDs problems was too much debt, so your point about baiance sheets is very valid

well perhaps i am being a little bit too dismissive of our views.i agree that caution which you perhaps personify and which actually i largely share ,does little harm and perhaps some good if it makes people think.the same cannot perhaps be said of over optimism.as you say its risk v reward and not for widows and orphans,but then nothing on aim is really.

well i would like to think so (this was sort of in the back of my mind when thinking about ongoing funding and good news begetting good news) but I'm not sure how much cognisance one authority takes of other decisions. perhaps they do although not in a formal way.certainly OTC approval would seem to suggest no problems with safety etc (as we have pretty much always known apart from a few modest side effects).obviously they have to do ongoing safety followup data which might i suppose be supportive as part of FDA application,depending on how much time elapses before that is finally formulated.

exactly right on the funding for marketing bald eagle.my post wasn't very clear on this, as i can see on reading it again. also things like responsibility for production costs will have to be factored in and here it may be that these would fall on FUM, but at this point it's all conjecture.obviously you are correct in that FUM does not have the resources in its present form for these sort of things but how they are allocated in the final agreement will no doubt depend on the respective parties' bargaining strengths,so again the number of interested parties would become highly relevant.as to the timing of eu approval i think the only posts from me on that subject are ones which urge caution to be exercised re the time scale and one yesterday which referenced the formal RNS stating approval was targeted for 2021. i certainly dont expect it this year, although early next year is possible imo. of course the ema can ask for more information but i don't think the distinction which you and other posters have sought to draw between the EMA procedure and the fda procedures is as clear cut as suggested.ive posted on this before and am not going to go over it again ,other than to say that FUM will have had sufficient guidance and collaboration from the EMA when formulating the data package to ensure that it is as fully prepared as possible for this stage of the procedure. they may well get questions for further information etc,but this is equally the case with the FDA submission when made. neither procedure imo precludes the possibility of further information being required and in substance the procedures are probably equally or virtually equally, exacting. it simply isn't correct I'm afraid to say the FDA tell you of any shortcomings at the beggining.they tell you what they want but can only consider the adequacy of what is submitted once they have it. tbh bald eagle it's a very simple situation here. this is a very risky business. for me the likelihood of getting approval is greater than not getting it, but the consequences of not getting it are pretty dire. investors have to weigh this up .do you risk probably losing almost everything if it goes wrong or do you risk the undoubted considerable rewards which approval would bring .you and i can argue the toss all day long from our different perspectives (and perhaps with our different agenda) but that's what it comes down to.our views are just background noise which all potential investors should ignore.anyone who is worried about losing all their investment or for whom it would have a significant financial impact shouldn't invest.those who can afford a bit of a gamble with funds they could afford to lose could do very well.

just for further interest, formal EUC decisions made (normally ) within 67 days of CHMP opinion, so by 27th sept at latest (jg said expected by 23rd)

https://www.ema.europa.eu/en/documents/smop/chmp-post-authorisation-summary-positive-opinion-fortacin-ii-30_en.pdf just for information and confirmation. reading the outline of the reasoning for the decision, in so far as i understand it.formal approval by EU commission must be a given.

i hope not steady.all these shares (and indeed all markets including the main ones) are very risky as I'm sure you realise.i almost made a fortune in the dotcom boom trading aim shares, but instead ended up losing one.massive amount of luck required really imo. that said VAL has great potential and I've been looking at its product portfolio in a little more detail this morning and feeling more confident.dont take advice from me or anyone else though.good luck for monday here.

well i don't know about that, but i do wonder whether some of those in say NYCT and synairgen may be considering how much mileage is left in those and might perhaps want to move some of their funds elsewhere.A £4m m/c is a good starting point for multiple gains if you are lucky.