Member Info for bignose58

And if anyone is interested in checking the Sensted trail progress, search under PSD502.

That still isn’t to say that the sp can go down further, which I am sure could happen before a us license agreement is announced. We all now know that the current (and for a long time now) liquidity is being driven by pump and dumps and small time pi’s who have no knowledge what the company has and in short space of time could become.

It certainly appears from my last post that our product has been a steep learning curve for PSNW, who, may now be able to produce a product without the problem of impurities..... It just goes to show a quick blow with an inert gas can make all the difference...too much air and not enough gas...lol

Also, what's very positive is the problems in manufacture should not alter the approval timelines themselves since they are two different things.

The last statement concerning "significant recurrent income" is very positive too since I would suggest once all things are sorted and approvals have been obtained, we could eventually, after many years, have reached the illusive "money tree" status.

Regarding the responses which, as has been noted, are quite detailed.....It's not the answers that are important (yes, they are important..But)....its the way the questions were formed and asked to begin with.....And of course JG obviously having a good day at the office...wherever that may be....LOL

Roll on a good US license agreement, which I am sure is soon to come.

And there's a little more....

It will all depend on the COGs (cost of goods) that the US licensee will bear. There is a US based manufacturer, Catalent that we have used in the development work but they were considerably higher on price than PSNW so RECORDATI chose PSNW. End of the day the US licensee will enter into the manufacturing and supply agreement so they may well choose a US based manufacturer that is FDA compliant.

We asked that question to PSNW about their cleaning process with regards to the can – they sterilise the can by injecting air into the can (and not an inert gas).

As you may gather Recordati has been looking for an alternative manufacturer for some time now – even searching as far as Turkey. However, they were fortunate to find a local manufacturer with the experience of manufacturing high pressured metered dose inhalers who had all the necessary approvals from EMA. For the Asian region, I think that if the local manufacturer comes up trumps on 6 month to 12 month stability data and is approved by EMA they may well migrate to it as its slightly cheaper on COGs than PSNW.

We are still hugely optimistic on Fortacin / Senstend – we just need initial approval in one of China and/or US with consistent supply and we then we should have an extremely valuable company with significant recurrent income.

No problem. Interestingly it does look like China may actually beat the US to the post, which is amazing given the company were still not considering that region back at the end of 2016 due to supposed red tape.

Anyway, at least things are moving with many fingers on pulses and all parties fully committed irrespective of the manufacturing problems which appear to be under control.

Enjoy... ;-)

....continued.

Recordati has recently received positive data from the proposed manufacturer at the 3 month time point on validation batches that are in line with release specifications (and not OOS) . Recordati mentioned that there were no signs of impairment of impurities (total and PGAK-1). The next time point will be at 6 months – say around mid-July that data will be available. All in all Recordati has advised that it now has the data to submit the grouped variations to EMA (i.e. change the manufacturer, in-process controls,…) and expect to submit the variation next month.

However, Recordati doesn’t know if it will be a type 1B or a type 2 variation as the EMA informed them it will decide after reviewing the data. Recordati has advised that it believes it has enough justification to submit as a type 1B variation but as said it will not know until after submission. The main difference between a type 1B and type 2 is the length of time it takes for approval as Type 1B is deemed a minor change so involves Qs&As while type 2 is a more formal approval as its deemed a major change – typically type 1B can take 3-4 months and type 2 >6 months (all depends on staff availability as COVID does impact on this).

The proposed manufacturer will use a different valve supplier so won’t require the valve stability work. However, as mentioned in the AR, if PSNW remain a manufacturer valve stability work will be required on the new valve. Recordati and PSNW are now in discussions on this so that new product can be on the market sooner than waiting for new supply from the new manufacturer. But that is a decision for Recordati– we have no say on this as they will need to submit the variation as MA holder.

With respect to my question on US phase III timeline. Importantly we now know the sites that recruit the most patients so the CRO is more confident in the speed of enrolment as it can target the high recruiting sites. We have also had a statical consultant look at the power of the study to make it an adaptive design i.e. to look at interim stages n-60 may be sufficient futility.

Wanbang registered the two phase I trials (now complete) and the Phase III (RCT) with the CDE website i.e. China Drug Trials http://www.chinadrugtrials.org.cn/clinicaltrials.searchlist.dhtml and So far 7 out of the 11 sites have been activated. 15 patients have been screened to date. Wanbang’s target is to have enrolment of 285 subjects by the end of October 2022. Of course this will depend on a number of factors, not least how COVID impacts the site(s) ability to recruit patients. Wanbang is in discussions with the PI to see if they can in add further sites to speed up enrolment. As you can appreciate Wanbang is in charge of the RCT and is pushing to complete the enrolment by end sOctober.

On 25 April 2022, MHRA approved the Company’s variation submission on behalf of Senstend to (i) to widen the PGAK-1 impurity to 1% and total impurities to 2%, and (ii) to increase the shelf life of Senstend to 24 months from 18 months. In light of MHRA’a approval, Recordati is now considering whether it will submit the same variations (using our submission data) on behalf of Fortacin to the EMA (as it is the owner of the European Marketing Authorisation it must submit the variations as Plethora is prohibited from doing so). In respect of why PGAK-1 has exceeded its specification at the 9-12 month time point after PSWN was successful in initially manufacturing for commercial release is a very good question – Recordati’s technical team, PSNW and our CMC consultant have thoroughly reviewed this to determine what is the root cause but PSNW was unable to identify what caused it to appear in the formulation. PSWN have run a number of studies but to date cannot determine the root cause. Speculation has formed whether the can (and its chemicals) react with moisture to form PGAK-1 but that remains to be seen. Recordati thinks if you sterilise the can with say blowing nitrogen or another inert gas, this may fix the problem and hence why the other manufacturer has been successful to date.

Recordati and Wanbang are both fully committed to the product. Recordati is going to great expense to bring on the new manufacturer (and are extremely positive that the new manufacturer can manufacture and release to spec) and Wanbang is now in the midst of an expensive RCT. So I do think that the commitment is there from these two licensees. There is sufficient production capacity to meet Recordati and Wanbang (at least for Wanbang’s first few years) requirements and we would expect that a new line could be added to increase capacity – that is a good problem to have down the road. But key for now is to get the product back on the shelves.

.....see next post

Amazingly, I've just received a response to all my questions and will post once sorted through.

Unfortunately not, but I do remember Michael Bentine's Potty Time. I'm also sure I remember he had a flea circus too. And of course the other program I remember was the Clangers who lived on and in a small moon-like planet. They didnt speak but just made whistling sounds.

Morning The.Italian,

Yup all rather confusing as usual, but then again "the muppets" were always a disorganized bunch. I have this morning sent an email to Kermit asking for clarification as the information provided leaves one very confused on timelines. I mean for starters; how is the 24 month new cap stability requirement going to delay things ?

Suffice to say. If I do receive a response, I will post the content here.

It's time to play the music
It's time to light the lights
It's time to meet the Muppets on the Muppet Show tonight....etc.

Dougie,

If what Dr Mike tells me is possible, the company stands to make a large amount of spongdoolies in the US. Its just infuriating that the companies own management are too incompetent to understand this, irrespective of them stating "the us is where the main market is". This could have been approved 2 years ago (and those are not my words) if money had been redirected.

That said. That was before the china syndrome was contemplated. So, even at a discount compared to the US, with approx 190 mill male sufferers alone, China still stands to be a force to be reckoned with income wise.

As such when both come on stream next year, it should propel the companies fortunes at least 10 fold and thats just to begin with.

All these manufacturing problems, I am convinced, could have been overcome sooner if our management were more proactive and had gotten involved on the case, which is a total reflection of their so called commitment to the product. i.e kicked some butt (PSNW was a new and unknown entity before our involvement and as such we should have been more proactive in overseeing the operation. I wonder how many times JG visited PSNW and watched the manufacturing process?). I am also convinced that had the chairman replaced all the BOD with experienced and motivated people who knew pharma and commercialisation, we would have reached the finish line in the US a lot sooner. All these things add up to incompetence in my view. there have been too many delays to be anything less.

And although one can brush over what has happened before, we should not forget since PI's are the one who are suffering not the management who still get paid large wedges and are given preferential options at our expense.

All we can do is wait and hope that nothing else goes wrong......Lets hope the equipment is repaired and the approval of widening the specification happens soon and without any issue.

soo.

Thinking about it; from what I remember, there was never usually an announcement of the Annual Report, instead it was just placed here left for investors to find.

http://www.endurancerp.com/template?series=9&year=2021#2

Which is where they have now moved it to.

..... continued.

Certainly a lot of vagueness, as usual, due to word use, however. If the variation is successful (Wangbang are still progressing with the phase III, are they not). It would seem sales could commence towards the end of 2023...yet another 18 months. What will be the sp by then ? The company desperately needs the income from any US agreement asap as I still don't see any income from the DLI white elephant hiding in the cupboard.

So reading through all the usual smoke n mirrors, I do have a few questions, which I will ask for clarification on some...

Why do they still refer to a 2017 valuation in the longevity market ??? "Longevity medicine, a US$4.2 trillion (and growing) industry in 2017". That's 5 years ago, has it gone into decline since then, otherwise surely they would be providing an up-to-date market value ?

"Will create substantial returns for our Shareholders in the medium to longer term". The life sciences investment strategy started in 2015, seven years ago. What is considered medium and long term when shareholder value since then has been decimated with still nothing to show for it with respect to shareholder return ?

"RCT that commenced in February 2022". So it has officially started then, but will it take 12 months given the current situation ? Luckily its not costing the company money, but it is still costing shareholder in delayed value whilst the sp declines further as investors slowly cash out due to the waiting game".

"On the assumption that the trial is sufficient to convince the FDA that the PEBEQ™ serves as an appropriate measure for support of a label claim, the pivotal Phase III study could commence in 2022, with NDA submission possible in 2023, giving a PDUFA date at the end of 2023. Could/would what ? They are affectively alluding to the possibility that the phase III may not even start in 2022. Why are they alluding to that given its already taken 5 years longer than they first stated?

Why are they only just now looking at widening the specification and increasing can size length? The problem has been apparent for a few years now (hence they are on the 3rd attempt at upscaling)
At least they have come clean that Recordati is going to use a local manufacturer, however. Wont they experience the same problems with the can, if it is not PSNW's fault ??? And how is it they are only now stating its also due to faulty equipment - surely this could have been identified a long time ago. Surely PSNW are not just using the faulty equipment for just our product.

Also, "This is designed, if successful, to meet Wanbang Biopharmaceutical’s requirements for China and the OTC’s requirements of Recordati in the EU and the UK". Does this mean that if "not successful", the OTC will not go ahead and Wanbang will walk away from the agreement because that's what is effectively stated ?

Since it was submitted in "mid December" (they mention EMA and MHRA, but do not mention the NMPA regarding China), when is approval expected to be given by any authority? We will be entering Q2 at the end of this week, so already 3 months. Will they advise the market of the results ?

...continued

Or document supply problems…….lol

Although the announcement has gone, the link I posted still works !!!.

Maybe the document is still there, but difficult to see due to the usual smoke n mirrors……..of course it could just be a technical fault…..lol

Is it me or have they removed the AR document ???

The.Italian,

Not looked through it yet, but will do tomorrow.

Looks like they are “undressing” them by finally exposing the problems to shareholders….. ;-)

2021 Annual Report has been uploaded + AGM notice.

http://www.endurancerp.com/ICMServlet/download/13-2563-4152/E575AR.pdf