Hand sanitizer and surface cleaner company Byotrol had a strong 2020 and are confident about 2021 Watch Now
London South East prides itself on its community spirit, and in order to keep the chat section problem free, we ask all members to follow these simple rules. In these rules, we refer to ourselves as "we", "us", "our". The user of the website is referred to as "you" and "your".
By posting on our share chat boards you are agreeing to the following:
The IP address of all posts is recorded to aid in enforcing these conditions. As a user you agree to any information you have entered being stored in a database. You agree that we have the right to remove, edit, move or close any topic or board at any time should we see fit. You agree that we have the right to remove any post without notice. You agree that we have the right to suspend your account without notice.
Please note some users may not behave properly and may post content that is misleading, untrue or offensive.
It is not possible for us to fully monitor all content all of the time but where we have actually received notice of any content that is potentially misleading, untrue, offensive, unlawful, infringes third party rights or is potentially in breach of these terms and conditions, then we will review such content, decide whether to remove it from this website and act accordingly.
Premium Members are members that have a premium subscription with London South East and have access to Premium Chat. You can subscribe here.
London South East does not endorse such members, and posts should not be construed as advice and represent the opinions of the authors, not those of London South East Ltd, or its affiliates.
Hopefully the SP will increase and the Exchange rate will be better for us.
exactly bignose.in his original email back in november jamie seemed to be saying that recordati didn't want to expend (or get their associates to expend) time and money on market research until the had approval for the change or at least it was looking that approval was likely (this is my paraphrasing of his email.) i am hoping therefore that they have already done some research on the basis that approval has been considered to be likely for a while now.i hope the statement that they are planning to scale up production is confirmation of this , but as you imply we cannot take that for granted. as ever it's wait and see I'm afraid.
Too true. How on earth do they know sales will increase if they have done no market research.....or have they ? Surely they won’t be caught with their trousers down twice ? They gave all the same carp about upping production in preparation for the initial launch which we now know was just pie in the sky.
agree with that dougie. sales figures have been the problem and may continue so to be.it will be interesting to see how OTC affects matters.
I appreciate all the commentators here for the inputs as its good to get other opinions. yes bignose and the italian i agree that we dont know whats going on behind the scenes and hopefully these developments and conversations with fda have taken place. it seems like a relatively risk free product compared to other drugs obviously, so if the process is sped up due to that fact that would be great, as waiting another 3-4 years for this to potentially come to fruition would be frustrating.
in terms of numerous pharmas being interested my only doubt is the low sales volumes so far in EU ?? , although i am not sure of these figures i remember announcements etc stating they were not very big.
its been a long journey but i guess this is a bust or boom for a lot of us here depending on the outcome of the coming year or 2 or 3
dougie whilst i agree that we need to read any statements by regent re intent or likelihood with a couple of buckets of salt, there is, i think, one scenatrio where it is just possible a potential licensing partner might wish to sign up before formal approval. normally i would agree that this is most unlikely, but here, supposing there were more than one interested party, then one of them might be wi ling to sign up before approval, say on the basis of a very modest sign on payment with larger milestone payments etc on approval. my reasons for thinking this is possible are that we are not dealing with something like an antibiotic or treatment for cancer or other diseases, where safety and efficacy issues frequently cause drugs to fail at the last hurdle. the successful switch from RX to OTC (about which i was always highly sceptical due to the rarity of success in this area and the relatively short duration for new data since the original approval) would suggest that safety data is very strong (possibly efficacy as well, although that has never really been any doubt in this area and this has been endorsed, i think, quite strongly by professional feed back). there is every reason to expect safety and efficacy data to be similar in the p2 and p3 trials, so licensees looking at matters may well feel that this is one of those situation s where approval is much more likely than not and as such might want to strike before rivals. we still have the question of whether the questionnaire will be sufficient, but i get the impression (just my personal take) that regent are fairly confident in that respect. so i think there are some grounds for, as i say, a modicum of optimism.just my opinion of course.time will tell.
I’m only going by what has been stated in the updates and in the content of emails received by me, although I’m sure the fact that the EU OTC approval, which appears to now be just a formality, has provided some added confidence, however. I can only speculate that the company must have discussed starting phase III before the end of phase II with the FDA otherwise they surely wouldn’t be contemplating it. That said, I do understand the company has been in constant dialogue with the FDA over the years where it surely must have been tabled ?
At the end of the day, the proof will be in the pudding or in this case, the signing :-)
morning bignose agree with that.does seem as though everything (apart from china etc)has been put on hold pending US progress,which is not really surprising as its always been regarded i think as key to success. permissable perhaps to indulge in a modicum of optimism.gla
Thanks for info Bignose. Glimmer of hope here and at least there seems to be some progress after a long period of stagnation. Perhaps all is not lost. Is there Some light at the end of this lengthy tunnel?
thanks for the input bignose but how is there any chance this could possibly even happen in the next 12 months if we will not be finished phase 3 by then?? i couldn't imagine companies would want to risk it before then ?
I also get the impression that if an agreement is signed with a strategic partner/s for the US market it will also unlock the possibility of agreements for the Middle East and Latin American regions since they seem to value the FDA approval process, which could occur anytime between now and this time next year. Just my opinion from the recent updates.
morning keith and bignose.i actually agree with you both in a sense. my reference to 3/4 years was a little tongue in cheek (hence my reference to will i still be here). i agree that we re likely to have some s/p changing news much sooner than that if things go well(particularly US licence).and of course bignose you are right to say it all depends onwhat our individual endgames are. i suppose what i am really saying is that the direction of the company should be well set within that period at the outside.gla
I think it will be sooner than that. It may take 3 to 4 years to achieve significant sales in the US, but then it depends what each of us considers as our end game?
The SP will have risen significantly (IMHO) long before then, based on a license agreement being signed and final FDA approval about the end of next year.
Of course if one is to include China in ones end game, then I agree 3 to 4 years, but who will be waiting for China before selling a few at a significant profit ?
This will all come to fruition as long as there are no further ****ups and incompetent delays.
The Italian, another excellent post and my enthusiasm rose initially only for my bubble of excitement to be burst by your comment ‘next 3/4 Years could see an endgame’. Blimey I’ve already waited years and another 3/4 years could seeM like an eternity!
well there are 2 or 3 positives. first that recordati must think there is some mileage in things if they are prepared to scale up the manufacturing process. however I'm not sure what sort of revenue regent could be looking at bearing in mind it only gets a percentage of sales and will undoubtedly be calculated on a pretty low sale price, i imagine. ive no idea really but its better than nothing hopefully. next its good that the FDA trial recruitment seems to be going well despite the difficult circumstances. also china seems to going forward, albeit somewhat slowly and that we can expect some positive news this month. i still cannot understand the FDA timescale and the roadmap. they say that on the assumption that the trial is sufficient to convince the FDA that PEBEQ serves as an appropriate measure etc, then the pivotal p3 work could commence in the latter half of 2020 .howcan this be? how can they convince the FDAa bout the questionnaire if they haven't finished the p2 trial? is it something the FDA can assess before the trial is finished? I've no idea. anyway not going to worry about it.no doubt it is intended to convey a sense of confidence and optimism to talk about commercial partners just head of or while they conduct P3 ( I'm not holding my breath), but if true the that would potentially be a game changer.we shall see. feeling very fatalistic towards matters now .next 3/4 years should see the endgame here.will i be here to see it? (feeling my age today). who knows. still fingers crossed.
glad it's out.only had time for a quick glance but will have proper look later.
Ill believe this when I see it....... but still positive in the right direction
Recordati, PSNW and the Group are looking into options at scaling up the manufacturing process
to meet the anticipated demand in OTC with the aim of manufacturing approximately 50,000 units
per batch order and reducing the risk of supply chain shortage and unreliability.
Still no mention of if the manufacturing problems have been solved.
Read all about it, Read all about it. Operations update........