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I'm not sure if the Bordeaux trial for Extavia is P2 or P3 but since there only 820 patients for three drug regimes plus a Vitamin control I assume P2 . Completion due August 21 so timing may be similar to our international P3 hospital and P3 Active for out-patients if all goes well in USA.
Thanks also to Kenneth and dactions for contributions on this thread.
Spinnaker
This is the pertinent extract from the link Saxondale posted earlier. I looks like a P2 trial in France for non-hospitalised Covid patients due for completion August 21 but started in July 20. It is a nebulised version of Interferon Beta 1b. Could this be the one the French Minister was referring to?
'Experimental: interferon ß-1b
Patients in this arm will receive interferon ß-1b (Extavia® 9,6 MUI/300 µg ) during 5 days
Drug: interferon ß-1b
A 10-minute nebulization, once a day, from the first day (day 0) to day 4, of 9.6 MIU / 300 µg of IFN-ß-1b (EXTAVIA®) diluted in 2 mL of water'
Best Spinnaker
Thanks Greend for the response and I note your points. No excuse for not replying to emails if they are seeking to be taken seriously as a public company with a thought of joining the LSE main list. I await a share price spike on the release of the Brazil details however I am not sure that will do much, there was a bit of a spike when first RNS'd . Maybe there won't be any significant move until the next cash raise and the pumping starts but note that is not intended until 2023.
Maybe that's cynical but I think I may be here a fairly long time.
Best
Spinnaker
Oh dear. The longer I hold this share the more I feel that Dr K has no real interest in commercialisation and seems much more interested in research and acquiring patents. Everything remains at very early stage. The governance of the company is poor and he appears to have no adequately heavy hitters on the board so runs it as if it was his own private company. The total debacle over listings changing, ADRs and Accustem is indicative that there is no thought of proper process.
My mood is not enhanced by the fact that my recent email to the company remains unanswered. Not even an acknowledgement. I wrote asking whether he was intending to try and get government assistance with progressing Foralumab trials for Covid both here and in the states since both countries are looking for appropriate new treatments and are prepared to fully or partially fund them. However it appears maybe he isn't concerned about the product for Covid any more. If he was we would have been informed before now of the proposals he had for progressing the treatment through to authorisation. Also we seem to have been waiting a fair time for publication of the data from the P1 Brazil trial. If he thinks a tie up with a large Pharma is possible then it is even more important to show that you are able and intending to progress in any event. Such a plan, costed and prepared, enhances the negotiating strength of the company.
Any self funded Phase 2 trial might be 12 months before completion and may well require more cash, if of any significant size, bearing in mind the two other trials intended this year. The timing is probably so far in the future that the situation on Covid prevalence and other drugs coming to market is uncertain.
Obviously, my negative take is exacerbated by the dire SP performance and the fact that I am reluctant to crystallise my heavy losses. At one time I could have sold out with only a minor loss but not now unfortunately. There are some good propositions in the pipeline but following the last nine months history I can't see that the boss has the people around him to focus, target and achieve monetisation for any of the potential drugs over which there are patents.
Spinnaker
Kenneth
Thanks for the update on your dad and I hope things go better from now on.
I wondered whether he was ever enrolled in the Evgen trial? Are you in Dundee by any chance since that is the base for the Evgen trial I believe?
On the Guillane-Barre syndrome, I believe this is usually post viral and usually temporary. A friend of mine came down with it over a year ago and it affected him very seriously for a few weeks. He couldn't walk or use his arms properly and lost loads of weight. I don't think it was related to Covid. He was about 63 and otherwise fairly fit but improved after 3 months with full nerve action now after going through a scary phase.
Very best wishes to you, your father and family.
Spinnaker
Does anyone on this board know of a single instance where a person has obtained treatment with SNG 001 either at home or in a hospital under the MAP protocol.
My last emails to both Consilium and Synairgen on this topic have not been answered.
Many thanks
Spinnaker
Dead right supermabs. The proof of the pudding is in the eating as they say. The next financial statement will be important to support the share price. Assuming there won't be too much delay in getting product to shops the identity of the tobacco retail chain will be public knowledge soon enough.
By the way, I went to the website (UK) to order and try some of the products and became slightly confused about the flavours of the Gummies since they were different flavours on the packaging to the description. Anyway, I have written to the company for clarification on that and a couple of other matters.
I only have a small holding here but the share price has done well over the months I have been holding and there is a huge amount of scope for growth. I am not sure though whether the new entrants into LSE in the medicinal cannabis field will impact on sales with ZOE since I suppose they will also be doing CBD stuff without THC as well.
Best of luck to all holders.
Spinnaker
I was pleased to see the sp improve today. The RNS does not state the name of the chain. I really can't think why not.
However it did state it was one of the biggest chains. Smoker Friendly is the only chain with more than 200 outlets https://tobaccobusiness.com/top-25-tobacco-outlet-chains-of-2017/ so I definitely hope it is that one. However due to the paucity of specialist tobacconists in the US I expect that Zoe will target the other chains as well.
Spinnaker
Wbernard
Thanks for your post. The 10% and 90% were an approximation I made from looking at the graphs produced by Dr Mina showing , from memory, viral load or virus shedding (i don't recall which), against time. I don't recall any distinction made between symptomatic and asymptomatic but assume as you say that the more relevant would be asymptomatic people. I have no idea where he got his information from. I think it may not have been from a particular trial but rather his understanding of the length of time there was virus shedding from an individual after infection. The video in this link is not one of the two I have seen before but the point is made at about 42 minutes in. https://www.youtube.com/watch?v=3seIAs-73G8 I note this video is from August. Mina's assumption of sensitivity or accuracy for LFTs has not been achieved, by Innova but his main point stands nevertheless. That is, that in certain circumstances mass testing by LFTs could be a positive move for public health and the economy.
I am hopeful that the 'Sovereign UK rapid test may have a higher sensitivity than the Innova test but this has not yet been demonstrated. In an event, my take is that the Gold Standard test will always still be required.
Best
Spinnaker
Deas999 and Wbernard
Thanks for your responses to my post.
Most of the content of your posts is unarguable. Dr Mina's argument is that the relationship of the two cohorts of undetected infected people is nothing like 50/50 but nearer 10% pre- infectiousness and 90% post-infectiousness on the grounds that an individual can become infectious (virus shedding) within 24 to 48 hours of infection but that RNA elements of the virus can continue to be detected by PCR 14 days or more after the person ceases to become infectious. Test on three consecutive days would catch the pre-infectious people but a single test on any one day would never guarantee that a person wasn't infected in the few hours before the test or even at the time of the test. Nothing will be 100% accurate and also no test would ensure the person tested negative would not be tested positive the next day or in 2 days time.
It is clear there are very valid arguments against the LFT but it seems to be the government considers that overall and with multiple regular testing they should be useful in reducing community infection rates on an epidemiological basis.
I need hardly repeat my belief that the NCYT PCR tests will still remain necessary and I expect an extension of the current contract and also further income from elsewhere will hopefully be reported shortly. The fact that I topped up at 1090p pre-results shows that I felt bullish at the time and despite the poorer than I expected RNS'd sales I still am.
Spinnaker
Hi Quickdraw
I do feel your position is facile.
I wonder if you have looked at any of Dr Michael Mina's videos over the last many months. His argument backed up by others has always been that the Gold Standard PCR test is not suitable for all circumstances and identifies as 'positive' many people who are no longer infectious. Quantitative analysis will of course get over this problem.
If the cut-off on any test including LFTs can be accurately set to identify only the infectious positives then this would be very helpful for public health. Please say you have watched his videos and then come back and give your comments on this argument. You must be aware that both LFT and PCR tests will be required for years because they have different strengths and weaknesses.
I am invested in Novacyte and the various LFT companies since last Spring and see no conflict in my position.
Best to all
Spinnaker
Good thread. Thanks to all.
What is the medical expert view on UK giving EUA based on P2 home trial data, added to the previous hospital P2 trial as peer reviewed. We were of course hoping that EUA might be given after the first trial but it appears there was no chance.
Will the aggregate numbers on the two trials be sufficient, assuming efficacy and safety confirmed, to grant EUA without P3 or are we totally reliant on Activ 2 and the US results and response? This may of course be unanswerable!
Thanks Spinnaker
PS No response that I have seen to my further enquiries re P3 and MAP from Synairgen or Consilium yet.
Father Ted
Thank you.
That is a really great podcast. This really is game changing. I thought OO would be restricted by the size of the HVivo facility but using an existing hospital wing is fantastic particularly when we are so short of bed spaces. I reckon there may be a few of these trials from private companies over the summer and the NHS may not say no to a repeat sub-let once the Covid demand has died down. Also new facility in Manchester?
Brilliant. I am going to try and buy some more stock tomorrow for the long term. May even put some in my SIPP.
Spinnaker
Sorry just noticed mis-spelled you're.
Your'e all right, it is fantastic news and as you say Newboy a world first. I am certainly not worried about a bit of exposure for the Challenge concept or the lack of OO name being mentioned, since we are now shown to be world leaders it will contribute significantly to the growth of the company in the future. All those that will be potential clients of the business will know it is ORPH.
I might be wrong and there may be a spike tomorrow anyway.
Spinnaker