RE:RE:SONA Saudi FDA status The above post is related closely to something I have been mulling over for some time. Why did Sona choose to carry-out the in-field testing in Saudi Arabia? Some seem to view this decision as a negative but I´m not so sure. For those who are interested in my thought process I will try to outline it here. These are only ideas and I am in no way suggesting that they are correct. They may be entirely wrong. There are those who may accuse me of wishful thinking and perhaps it is but here goes anyway.
1. SONA maintains a partnership arrangement with MRI Global and apparently are very happy with the work done together on Covid Clinical Trial work and it seems that MRI have no problem with Sona. Why then, when asked to do in-field studies, did SONA decide to use SAUDIVAX for these studies? It might seem a strange choice.
2. SONA signed a collaberative agreement with SAUDIVAX on 30th June 2020 and seem to have formed a very close relationship since. SAUDIVAX is a joint venture between PnuVax (7 billion market cap with close relations to Gates Foundation) and UYC inc. Saudi Arabia.
3. SAUDIVAX have very close contacts to the Saudi Government and are very influential. Crown Prince Muhammad Bin Salim was present at their inaugural signing. Their Mission Statement is to be the premier manufacturer and supplier to KSA (population 35million), GCC (54m) and OIC ( over 1.8 billion) and they have the connections to do so. Saudi Arabia itself leads the OIC and has hegemony over it both in terms of influence and finance. They also want to be accepted as the de-facto and permanent leaders of the Arab and Muslim world and have spent and will continue to spend massively to cement that position.
4. The trial partnered with the King Fahd Research Centre, King Abdulaziz University and all of this at the King Abdullah University of Science and Technology Complex ( KAUST). Who else is involved and based at KAUST? BECKMAN COULTER of CYTIVA and SAUDI VAX. The connections go on and on. Would SONA have carried out the trial there without having first discussed it with CYTIVA , with who we have a very close partnership and are working hand in hand on the test programme ? I doubt it very much. To be honest it´s unthinkable.
5. That brings us back to the above post which says that FSDA Approval requires prior approval by another major regulator eg. FDA, HC etc.. In principe that is (or was) true but the FSDA has its´ own COVID EUA, issued on 12.04.2020 ,where it specifically says that the medical device/ product should be licensed by other regulatory authorities (if possible).
6. Now the SFDA did not put that (if possible) in by mistake.They were thinking to the future. When might they use their discretion to approve a test without other prior approvals? Perhaps a test with Clinical Trials carried out in their own country, led by a well-thought of Saudi Company, carried out on Saudi patients, with the co-operation of their own foremost medical services? That has to be a distinct possibility.
7. If the above analysis is accurate it would be a masterstroke by SONA implying foresight, immaculate planning and great collaboration with a specific target in mind. It would give Sona ( as I don´t know of any other Middle East projects out there) priority in a massive, massive market that would be financed by the Saudis to supply the whole region. Only they could do that. SAUDIVAX were very positive about the results( even more so than Sona themselves admitted to) they outlined their plans to commence manufacturing, stated their intentions to submit for Regulatory Approval and to plan a Saudi Screening Programme.
8. Not long after that SAUDIVAX tweet their Twitter feed was taken down. Why? Did they give away too much too early? Perhaps Market sensitive information to those reading between the lines?
Anyway as I said at the beginning all the above is far from certain but I have been pondering on this matter for several days and these are my thoughts on a possible scenario. Please take it at face value, do your own research and come to your own conclusions. It may indeed well be simply wishful thinking. GLTA.