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The PLE Companies House filing sheds more light on the US regulatory situation. Not that it wasn't completely obvious from the Phase II data, but the FDA do not believe the PEBEQ to be fit for purpose and a second SPA request was denied last November. Strange not to have been mentioned back in March this year.
Cited verbatim below, although I've left out the waffle about "many positives in the FDA's response". True, nothing to stop the Phase III proceeding without a SPA or validated co-primary endpoint. Well, apart from no cash and zero chance of approval.
"On 2 June 2023, FDA replied to Plethora's request for SPA with a "no agreement" statement. The major observation is that the FDA is requesting on Estimand and SAP that was subsequently submitted to the FDA" ["estimand" relates to definition of treatment effect, SAP is the statistical analysis plan].
"On 6 November, the FDA replied again with a "no agreement" statement. The FDA is requesting that we generate evidence in respect of PEBEQ item 3 is "fit for purpose" and in the FDA's opinion this cannot be analysed until after our Phase 3 clinical trial is complete".
Https://s3.eu-west-2.amazonaws.com/document-api-images-live.ch.gov.uk/docs/IaOYW6Baq_3LkNpTu0w7ZyDCO0AS_q-nlSn7iUTHYJg/application-pdf?X-Amz-Algorithm=AWS4-HMAC-SHA256&X-Amz-Credential=ASIAWRGBDBV3EH5YPCNL%2F20240619%2Feu-west-2%2Fs3%2Faws4_request&X-Amz-Date=20240619T181614Z&X-Amz-Expires=60&X-Amz-Security-Token=IQoJb3JpZ2luX2VjEIj%2F%2F%2F%2F%2F%2F%2F%2F%2F%2FwEaCWV1LXdlc3QtMiJGMEQCIBz70YoOgFtyu1pXNwKMBcroTnMMES1uztKizeRnYpvtAiBCScnEjf3TbxmNglKJwcVKwpYBZWWUdNcX1Ci3%2Fqdozyq7BQgwEAUaDDQ0OTIyOTAzMjgyMiIMVcj0Mdx9su0mAdSfKpgFIduOAuh7vjmhVHgXRsGObdEejBXs4%2Fr0V4%2BrkW5nHeSpuHF79BWAVnpfoYnlQQR54GwCeCJMuL%2FdZ35OZLbGnAWcSONcpoiRLDKQH5uWcdJhwO1W4r%2BpajBI1B21APzydPYlrYkMcH3Fxmos%2FnUIuva%2FA4CWIOpxUZgAAt%2BqdpvGDqOj4ea6Dx8PWMVs9edQp3l33FJw9buhVN1j%2FKgJJBAOQozARxLXolUYYh%2FDBKAicdMQMEMxE%2FCT%2B8nc2CH3bpd33Ig5urcfA%2B7l9WYN5EWRoq%2B4UD9WDKu420%2Fz95jnSv4ZBSkYIMNLbIqrgyHs6zeOBpCeoKXl5ZS9bYdHsCisgWy8%2FXMiNOVpUNwoGRaWH6vdji0zvqDXv0xVwQmZ9IehP7QaaxriSkZXBgLquw4mhnJu33MeVonm%2BBxbbJp7TMRBgMIM%2Bv5Xe0X6Rqi7esCFbQgFfPEnnzwCv8Uz1d6gDyvYxX8cAC2FthW9U6pFQWJdk23gtA6pJ28N%2F2MjxkGuTELZKBglh9v9xpjw%2BH80Yw1uKPk8HBMJCG%2Fl83XTRpsO%2FFRPz4Qdo4K1lGGm7ebeT0UVEoHQjrKIiMe%2BjMS%2FlyZ0E%2BwLcE7D3leMQwNhiB8iUgg1kMe0SsAvCphOZop7L0LLiRzycq2XzUBd9uZhIvuWKisMfxAs655z0jryMP4Ejvrsz2QEX3UcfplrgiTk66VkZ6CWmBwErWVWVOJl1zGWMlDR%2FC%2F%2BZojaYnid0iOeAMed2ZnChqNamekG1%2BQzgQXNS5LluOaSAH%2Bd53h6G9LW%2BE%2BC4xyAbWn9v6g1Ie3%2FfFwM1IDsn5ZTM91j%2BremvEM3Pi4mqi73Dpd0S8UgjGZgYAGM9ON%2B9bAf9EBLZ7OVic%2FicjDK68uzBjqyARBvi978CXFPH8Pa%2F82a4AKVfZVv%2BNq0Tmt83RhxDFZ4MNxtipNtmiDjVGIbhWf8DDA138S%2BJkYS7Ckh02KSkKScx26qTeGpwBSJpfcxKK%2BsOkc0XMO8mjaMlMGFlDHgbmp%2FoQJlU3mc0RByQQyLUp3tPritNmP954eY%2F%2BqfgavndqBnFWmg7kjGK0GHk5l5%2B1YkFCfLwKKhFbL%2ByPuopQOS7IE7s3MHhIYl79Pdl6CWzTM%3D&X-Amz-SignedHeaders=host&response-content-disposition=inline%3Bfilename%3D%22companies_house_document.pdf%22&X-Amz-Signature=cd37402585f23e0ac262a1e8e951fabc1fe924a3fe5c9a776c809591b026ccf7 here is the full statement so we can read it for ourselves. the fact that this level of detail has not been give before and by regent rather than filed in the plethora accounts, simply beggars belief. i have never felt more angry about the bod's conduct.
For some reason the link won't copy.just google" plethora solution company house" and read annual report for year to dec2023 under filing details.
Allow me:
https://tinyurl.com/mrxth53z
Morning The.Italian.
Nothing but lies and misinformation. RPG in its last Op updates and interim and final results has done nothing but allude to the fact that all is going well with the SPA, however. On reading the PLE results its clearly a different story. The FDA has made a "no agreement", not once, but twice regarding the SPA. In the end the FDA are of the opinion that it cannot be analysed until after the phase III clinical trial is complete, which in my book makes it worthless as it's meant to have helped assure licensees to a point where they may commit to signing an agreement.
To be honest, I have given up hope of them getting FDA approval and signing any agreement with a US licensee since an agreement would have been signed years ago if they thought it was commercially viable.. Also, the FDA deliberately appears to be trying to drag the process since PLE had an unambiguous FDA agreement in Mar 2014 and even suggested approval by June 2017. This has all changed and currently we are looking at 10 years since then and still it's unfinished. That and the fact the EU now has OTC approval and it has been on sale for several years with all the accompanying data, which cannot be ignored. They even have the audacity to state only a few months ago that "positive progress made between the FDA and Plethora regarding the Phase 3 studies protocol and the Special Protocol Assessment (“SPA”).".
I am now looking towards the Chinese approval as they could really turn the companies fortunes, however. Even that has now stopped dead in its tracks since Wanbang is now in negotiations with the new manufacturer, which is taking longer than it should have given that they shoud have started negotiations nearly 2 years ago following the EU approval. This tells me that once again the company has not broached the subject or even forgot to inform Wangbang of a new manufacturer. It's the same incompetence as before. We have now lost close to another year in delays re China (If I remember correctly, the first was due to PLE forgetting to check if the Chinese authorities had all the necessary documentation on the chemical products to be used).
There has been no indication to date if PLE has submitted the application to add another manufacturer or even if that has been approved let alone any agrement being made with the new manufacturer.
Once agin the delays are RPG/PLE driven through lack of experience and incompetence.
The timing is now again critical regarding the expected 5mill USD NMPA approval milestone payment and remaining monies from the recent loan.
As you state the bods conduct is deplorable. If one onts a better understanding of what is going on, one has to read the annual report of a sub company !!! is that even legal since RPG should be reporting to shareholders not PLE.
Also, whats interesting is that the PLE AR includes the statements. "(please see our previous announcment of 4th July 2022 and our interim report for the six months ended 30th June 2021.
PLE have made no such announcment and dont even submit interims. This is because they are referring RPG documents yet no ref is made to that !!!
Furthermore, I see the chairman stateed in the AR that the new manufcaturer and Wangbang had finalised the agreement at the end of 2023 (nothing to say when it had been finalised so one has to assume the end of 2023 since its the end of year results). so why another 6 months ? They dont even say if the NMPA has approved the other dossier regarding accptance levels which was submitted at the end of H1 last year. This aparently is needed in the NDA submission.
Morning bignose. thanks for analysing the situation in far more detail than i would be able to do. completely agree with all you say .i have also now written off US as a relevant consideration(except as a potential for more dilution etc if they do try to go ahead).i did note the reference to china as the main market.have they said this before? they used to say it was the US, but not sure what the line has been for the last year or so.
Has anyone emailed RPG/ anyone who on the BOD about this? total lack of regard once again for shareholders .
I have actually emailed JM,JG etc telling they they are a bunch of useless dciks. It will be interesting to see if they reply. Why the info regarding SPA is in the PLE report but not in the RGP share holders report which states everything is ok.
Good man, bignose. let's see what they say.
They owe an explanation let’s be honest. This isn’t the first time we have been severely let down
Not in my nature to say "I told you so", but hey...I told you that this was dead last February when the Phase II data was made public. Caveat emptor, Mr Praline.
Now let's see...what else might they be gaslighting you poor old shareholders about? Shortcomings in the NMPA dossier? Perhaps something to do with the requirement to include measurement of the genotoxic metabolites 2,6-dimethylaniline and o-toluidine in the Pk/tox studies? As expected, no issues in male or female subjects, but bless me, manufacture and specification have changed since Oompa Loompa clinical supply and of course , there's no genotox data for the Made in Italy version.
Hmm...wonder if the NMPA will let this slide...? And 14 months on, still no release of the allegedly stellar Phase III data.
Tick...tock...
Well I did get an unexpected response from Jamie which actually was surprisingly civil given my content.
Anyway he did point out that the non agreement statement was included in the Chairmans statement in the AR, however. As I responded and pointed out to him, it should have been included in the AFR since that document paints a totally different picture as to the progress being made and possible future sp impact.
He obviously has and will not admit any wrongdoing.
In addiiton I have asked for more info on can sales given they have stated, after Recordatis resumption of sales, that 30k cans every 5 months is positive which is nonsense. Especially when PSNW upscalied production to 50k cans every 6 to 8 weeks and back then a can was 100EU/can compared to the current 40EU/can. He has tried to allude to the fact that its considered as insider information, however. I have pointed out that as he has stated the manufacturer can produce 5mill cans/year and that sales would be exponential, surely its time to provide an update on figures as 30k cans/5months is not positive an any way.
Anyway, will be interesting to see if he responds.
Morning bignose. thanks for that. perhaps the civility of the response is indicative of a tacit acceptance of the criticism.as you say,obviously that acceptance(if indeed there is such)will never be acknowledged explicitly. perfectly valid questions re can sales in the context given.not holding my breath for a detailed response.good of you to press these issues.
Thank you for sharing Bignose. ridiculous that investors need to go directly questioning the people involved as we are left in the dark