The London South East, Investing Matters Podcast - Episode 5 featuring Annabel Brodie-Smith, the Communications Director at The AIC is now LIVE. Listen here.
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Soon back down to 0.6 (old money).
Surely these large swings don’t instil any confidence as a long term investment. Granted some price movements are because of mineral market price but not to the extent we have been seeing in the sp. It will be interesting to see if there is a progress update on what the company are trying to achieve. I would suspect this last rise was initiated due to the 5 to 1 consolidation and to allow institutions who bought at the recent placing to offload……but then what do I know …. :-)
I can appreciate the confusion, but it's not that complicated.
The 505(b)(2) route is the only way in which ERP can satisfy the fixed-dose combination rule (in essence, that each active is essential for efficacy without compromising safety- the nature of the product means that this cannot be determined separately for lidocaine and prilocaine). The big hope is that the FDA will accept safety through reference to data accumulated for comparable products, actual product safety to be confirmed by a bridging study with a selected reference product.
Clinical data still needs to be generated through one or more pivotal studies, the complication being that the PEBEQ endpoint only goes out to 1 month, whereas the optimal Tx endpoint is 3 months, hence the shift to an "adaptive design". Very intrigued to see what this will look like and how it impacts on label claims.
Cutting through whimsy, there's no cunning plan involving OTC- combination of actives rules out monograph submission. There's no "vast database" of safety or efficacy data (have a read of the full CHMP switch document), only the EudraVigilance adverse event capture. Fortacin was never reimbursed so no filled script tracking, actual usage is unknown. Since the manufacturing process for the 20 dose can has never changed, safety data gathered over a decade ago (and for the more recent Ph II- total of under 300 subjects?) could be included in a US submission.
morning dougie.it would be good to think so and yes the silence does suggest something might be afoot.it's a good point which you and bignose make about the weight of data and with the 505(b)(2)route they can use data from sources other than themselves,which may be part of the plan.lots of questions!!
They must be upto something like this behind the scenes , there must be a left field tactic they are going after . Hopefully sooner rather than later it is realised . There has been enough data to show the product is safe and effective .
morning bignose.yes interesting article.we seem to have entered some rather cloudy waters now,with the reference to the RLD protocol and trial.i have spent some time (yes i know i should get out more) trying to work out why they re now trying to do,but(no surprise)failed to come to any real conclusions,as i don't have the technical industry knowledge and understanding which would help and of course ,we have not been given much to go on by ERP itself. i'm hoping the next operations update will clarify exactly what the new strategy is.the article does suggest a movement in favour of OTC,which of course was exemplified by our own success in that respect,but whether this can be incorporated in some way in other regions only time will tell.fingers still crossed!
Pretty quiet here of late even with the sp bouncing around on miniscule volumes producing large % swings.
Although the article is from Sept 2020, it may be of some interest since it cites our product at the beginning of the discussion. ====>>>
What is interesting is that the FDA (Janet Wood**** (director of the CDER) - a very appropriate name when considering the likes of ED) do not dismiss the possibility outright. See the 5th paragraph regarding the Frederick Mayer petition and Janet's remark "if a medication is appropriate, effective, and safe for them to use, there could be increased switch activity in the United States as well" PLE certainly have a vast database of subjects who have used the product with next to no side effects.
I wonder if any of this is being discussed with the FDA/Japanese and possible Licensees ????? Food for thought ?
https://oilprice.com/Energy/Energy-General/A-Copper-Crisis-Threatens-The-Energy-Transition.html just for interest.i know nothing about mining and commodities,so no comment.
week keith i admit that i do enjoy posting on here as it is by far the most civilised and amicable one i have come across. one certainly need a a very long tether to stay the course here (reminds me of the very long spoon i use when supping with the devil) and i can well understand you getting to the end of it. tbh im not really very optimistic about the future but i am reconciled to seeing it through at least for the next 3 years or so (my personal timeline from an age perspective). doubtless a triumph of obduracy over common sense.as always time will tell.
I have to say, I read your posts (Bignose and The Italian) with interest and admire your unremitting optimism. This, of course, is always subsumed by the ‘reality’ of Alchemy’s subversive but, not unfounded, posts. I must admit as a LTH I am at the end of my very long tether regarding the ineptitude , continual procrastination, inexplicable rebranding and complete lack of competence. I try hard to be positive but, my god, it Is difficult with this litany of utter buffoons supposedly in charge!
no chance of that bignose! lol
Yes it surely could, however. I didn't want posters to think I was barking mad......woof. ;-)
morning bignose. i thought it was a typo for "collar" but im not being "dogmatic" about it.
Or should that have been dogma market……lol
Did you read this part...
"The company is developing novel therapeutics targeting aging in humans and dogs".
Who let the dogs out.....woof .......woof woof .....woof woof.
That's gotta be a multi trillion dorrar market.....Meeoooww....
What’s your thoughts on future time frames now we into 2021 guys ? USA progress must be due shortly , I mean shortly by endurance timeframes so within months , not years . Thought we would of got more clarity about plan moving forward regarding the most recent update we got also
courtesy.i really can't spell very well.
https://www.longevity.technology/genflow-to-become-europes-first-longevity-biotech-ipo/ curtesy of the seed board.not suggesting it is of anything other than tangential relevance,but so many pies and so many fingers.shame most of them come out underbaked!
I wouldn't fret Bothwell. This has the whiff of vapourware around it. And, with no evidence to the contrary, Fortacin is probably at least as good as the hundreds of delay sprays and wipes which have been marketed for years.
No, you are right- approval will require efficacy data, since no predicate device. Approval, as with other novel neurostimulatory devices, will be by the de novo path. What "efficacy" means will depend on the label claim- objective change in IELT from baseline compared with sham device (or active comparator?) might not be enough.
Concept itself not novel, recollect being approached by an Israeli VC a couple of years back which had backed a company (something like "Virility Health" or "Virility Medical") which had generated clinical data using an off-the-shelf TENS machine, and was looking to develop and test a patch-based electrode set-up. We politely passed on this "opportunity".
TBH, I personally think it will be far too cumbersome as apposed to just 3 squirts, a quick rub, wipe n forget situation, although I’m sure some my want to try it.
Mind you, we have yet to reach the finish line and we know how long it’s taken the clowns so far…….. they have still yet to deliver.
don't want to spend too much time on this,as i really don't think it is anything to be concerned about,but I've had a look at the 2021 video presentation by the ceo.he is waving the patch about(yes its huge!) and it looks,shall i say.a tad awkward.he talks about FDA approval and states that because they will not be making any efficacy claims they will only need to deal with safety.no idea if this is correct,but it didn't sound the most convincing sales pitch. i thought for FDA medical device approval a basic level of efficacy had to be shown(i.e. it does what it claims to do) but perhaps im wrong. obviously if they re not proposing to make any claims,then wouldn't have to demonstrate much in the way of efficacy,but perhaps not the strongest marketing strategy.
"clinical" was the word i was looking for rather than "calculating", although both convey my reservations in slightly different senses.
well i certainly hope so bothwell.perfectly reasonable to have it drawn to our attention,but putting aside all the obvious jokes etc,i think one has to look at it in a fairly objective way and consider how popular such a device would be, even assuming it can get to market.i haven't looked at the video but my initial reaction is that it is far too mechanical and perhaps calculating to appeal widely. of course it may simply work by providing a distraction as you grope around(sorry )for the right button to press! not sure its an app i would want on my phone.
Surely our product is better than this one.