RE: SPA kicked into touch...twice.20 Jun 2024 03:20
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.
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