RE: Today's runs30 Mar 2024 05:34
Although I am somewhat disappointed with respect to the Chinese submission as it now delays possible approval by 6 more months which will add time to when any income stream is seen. If they have not sorted a manufacturer till now, I would suspect they wont have sorted out distribution of product etc etc either, meaning that any income from the 9mill target sufferers may not happen till the end of 2025 or even the beginning of 2026 and that's when sales will start so RPG may not see any money till towards the end of 2026. If that is indeed the case and there is a good possibility that may happen, what money will the company run on ?
There may be a 4mill usd cash injection (less tax) triggered by the approval, but that surely will be used to offset any loan to get the company even to that point. Surely there will be a point when even Jim will get fed up loaning the company money and seeing no return. And then what about the monies needed for the phase III they cannot run a phase III without spending more money???
The FDA process has been nothing more than a car crash since the beginning. They wrote a lot about how it was there main objective however, its been nothing more than a disaster time after time. The original unambiguous FDA RNS in March 2014 with a follow up to say they expected approval by June/July 2017 was nothing more than lies. There has been no announcement as to why and what had changed changed. Instead all they did was kept giving excuses and delays. The phase II which was for only 100 subjects (I'll write that again 100 subjects !!!) has so far taken nearly 6 years from when shareholders were told recruitment had started, which it didn't. It then started at the end of Dec 2018 and was supposedly going to take 15 months and be completed by March 2020. 8 months into the study, we were told that the study would be completed 3 months early and be completed by the end of Dec 2020. Meaning that over 50% of subjects must have been processed, however. In Jan/Feb 2021 shareholders were informed only 15 subjects had been processed, which meant effectively the statement advising of a reduced timescale was nothing more than a known lie. And what about the licensee. The media were told in 2014 that the company was close to signing heads of terms with a US licensee. Yet still no reason was given as to why they walked away and stayed away.
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