Member Info for The.Italian

obliged for that MrH.

fair enough offer.i also did very well indeed out of this first time around (sold out on the spike to 18p).perhaps i am being overly sensitive to some other posters who seem to be delighting in the current misfortunes.aplogies if i have unfairly included you in this categorisation

morning.yes excellent news.very pleased!

dan,i don't have a problem with justified tergiversation,just the way its expressed.

lnr i think you will find that this BB will remain open for quite some time even after delisting from aim.there are lots of examples of this,but probably sensible to engage in some posting activity even if nothing much to say,just to demonstrate interest in the board.also i assume the telegram group will continue,although i am not member.

well offer that is really encouraging to hear and it reminds m of your post on 3rd may 2018 when you said you really believed in the potential and were sticking with it for the long term.your constancy is truly impressive,

morning mr h. yes still here and more interested in tomorrow than the didactic and self congratulatory musings currently occupying this board.

it is indeed,bucolic,it is indeed.

DandD none of us have any idea when deal/licence will be announced.any opinions will just be guesswork and personally i prefer to assume it will be quite some time away,as that way if its earlier ill be pleasantly surprised and if not,i won't be disappointed. imo the nature/quailty of the deal ill far more important than its timing.just my opinion

with that in mind i have been looking at things whcih might help me understand the issues better https://camargopharma.com/resources/blog/fixed-dose-combination-products-navigating-the-combination-rule/ i found this quite helpful and the example they give is quite instructive.i have also found https://camargopharma.com/resources/what-is-505b2/ to be very informative,if that is indeed something in contemplation.it is worth reading ,as without wishing to minimise in any way the complexities, it does suggest to me at least,that they may well be looking at ways to expedite the application or at least maximise its chances of success.not all bad news imo.

some interesting food for thought over the last few days.thedifficulty i have is what i can only assess what we are told in a fairly superficial way,as i lack any background in the appropriate disciplines ,which would better equip me to do so ("O" level physics 60 years or so ago isn't really going to cut it). however i don't subscribe to the maxim that a little learning is a dangerous thing.i prefer the philosophy of a former partner (in a business sense) of mine who was fond of saying all knowledge,however small, is of value tbc

well dougie that is what i am thinking and hoping.they state they are seeking....concurrence on the protocol of the p3 study and agreement on the RLD study so seems to contemplate 2 studies.perhaps the idea of the adaptive trial is to enable them to take account of the other one and vice versa.

morning heimdal and dougie.you may all be right heimdl and im not suggesting its a bad sign,but it doesn't explain what the RLD is they are proposing to reference if they go down that route and the is what is puzzling.anyway looks like we will have to wait a while for clarity on the next step.it may turn out to be a positive step.

final bithttps://bmcmedicine.biomedcentral.com/articles/10.1186/s12916-018-1017-7 adaptive trial link. i do hope this makes sense and apologies again but my computer glitch won't go away.

https://www.mypharmacy.co.uk/product/emla-cream-5g/?gclid=EAIaIQobChMI_ayp_7Pp9AIVk5ftCh1tsAc0EAAYASAAEgJd7_D_BwE can it really be EMLA cream as suggested? for those interested the nature of an Adaptive design is explained in the next link. all very odd.no idea if its because of a problem or whether it is seen as a way of expediting matters or reducing the trial burden(there is nothing explicit to suggest this but i'ts hard to make sense of it in any other way.if anyone can help i would be grateful. tbc

continued...RLD is an approved drug product to which new generic versions are compared to show they are bioequivalent. does this mean(i think it does)the we are now pursuing an ANDA and are seeking to shorten the procedure by claiming bioequivalence(and hence safey and efficacy)based on an existing drug and if so which one?tbc

conthttps://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-glossary-terms you will see from this link that an RLD is a reference listed drug (the correct terminology appears to be"referenced" as it is referenced in the following circumstances). a drug company seeking to market a generic equivalent must REFER to the RLD in its Abbreviated New Drug Application(ANDA).tbc

I've been looking at the last announcement with reference to the FDA application and am completely confused as to what is now going on.first apologies for doing this in sections.in all(well the last four or five I've checked, but you get the point) the fda application has been referred to as NDA (new drug application).we are now told that an RLD type c meeting has been requested for feedback on the RLD protocol. tbc

yes indeed i did see them on my phone,but i can't post on that.excellent job! perhaps we will now get a celebratory RNS to cement the occasion.on a serious note ,some licensing news would be welcome,but these things rarely happen as quickly as one would like,so we just need to be patient.

not sure the16% quoted spread makes that particularly appealing. dont know what actual spread is as haven't tried any dummy trades.