Member Info for sicilian_kan

In which case you trust him a little bit... ;-)

From the AGM on Monday this week, the Chairman stated:

"So there are absolutely no misunderstandings, we're committed, they're committed [Avion]. Our target is to get the Phase 3 started before the end of this year. We actually see no reason why it shouldn't. We don't see any hurdles. We are actually going through a process with the FDA at the moment, which is a process. We have to go through it, it's regulatory, but it shouldn't send any negative signals to anybody at all, quite the opposite. We are getting really, really good feedback from the FDA in the very, very supportive, meetings that we are having. So I hope if anything I can alleviate people's concerns on that"

Hi wigwammer. I think the US patent on lupus is to 2027 for lupus and 2031 for other indications. But yes, they also get a period of data exclusivity in addition. In Europe there is 8 years' data exclusivity plus 2 years' marketing exclusivity. In the US I think it is 5 years. Happy to be corrected - my research on this is not lenghty.

They had Lanstead throughout the last P3 trial. Didn't stop the share price rising from 20p to 190p.

FWIW, I think IMM is substantially undervalued at the moment and I am expecting a sharp rise in the coming weeks. It looks as if IMM (market cap just £21m!) will be entering a Phase 3 trial fully funded by Avion, whilst retaining 100% of European rights and up to 17% royalties on US rights, in a $bn+ market, with other indications to follow.

It matters not whether the end result is positive. In my view there will be a re-rating in anticipation of P3 being confirmed, and then further uplifts as the P3 is confirmed, and as the trial starts and progresses. Simply because the market cap is just far too low for where they are and because the market hasn't yet bought into the idea of P3 starting.

I think we have seen the low, and I can see this doubling fast in the next couple of months. I've been accumulating in the 8-9p region. As ever DYOR and only invest what you can afford to lose in case things go against you.

They can add far more value than 7% for the £20m cash they now have. Prostate is a massive opportunity with excellent results to date. 116p is also a good price considering not long ago we were in the 80s. Also means there will not be endless placing talk when the good news comes in from the FDA - no need now it is out of the way. Very sensible decision in my view.

Good find miavoce. The key I think is this passage added into the changes:

"In response to the COVID-19 pandemic, the treatment burden for patients has also been reduced where possible by conducting remote assessments via telephone or video conference, and by limiting the duration of SCIB1 treatment to 6 months, though pembrolizumab treatment may still continue as standard of care at the discretion of the Study Investigator."

So SCIB1 was to be given for up to 2 years and now it is to be given for up to 25 weeks.

https://www.lsegissuerservices.com/spark/FaronPharmaceuticalsOy/events/04110470-3c65-4dad-ba56-54b27e83f27f

Fuller article here: https://www.telegraph.co.uk/news/2021/03/18/10m-uk-bound-indian-astrazeneca-vaccine-doses-held-indian-government/

"The UK's vaccination efforts will be paralysed from next month because the Indian Government is temporarily holding exports, according to the CEO of the Serum Institute of India (SII)" see today's Telegraph Live updates for more information at https://www.telegraph.co.uk/global-health/science-and-disease/covid-news-vaccines-europe-von-de-leyen-astrazeneca-oxford/

And for completeness, I add the vaccine nationalism in India now refusing to export

Yet again we are seeing the very serious impact of countries carrying out vaccine nationalisation, with the EU warning about an export ban of the Pfizer vaccine to the UK.

Events like this demonstrate why the SCLP / Nottingham vaccine being developed will get maximum support from the UK government, and with that from major pharma. A new variant independent vaccine manufactured in the UK will be a massive priority for the UK and its security going forwards.

The prospects of a deal here in the coming 1-10 weeks - and of the announcement of the start date for SCLP's Covid trial - are very high.

Agreed, and no one calls a holiday on September 20th a summer holiday. Spring is March to May. Period. Next we will have people suggesting that a billion is a million million!

Thanks chillpill and miavoce. Awesome news. Particularly “Human trials are due to start in the coming weeks and we should have early results by the beginning of the Summer”.

Quicker than even many bulls were thinking possible - and a great way to set up the weekend. I remain of the view that a COVID deal in the coming weeks is likely.

I agree with the principle, not necessarily the 6 months point. By way of example, I hold a share where the CEO was heavily criticised 5-7 years ago for going down the wrong FDA path and for getting involved in a repro agreement re some of his shares without initially declaring it to the market. That led to many being put off investing in the company. Now they are going down the right FDA path, the share price has doubled, and one parks to one side what happened 5 years ago. It just is not relevant any more. Not forgotten, but no longer of relevance to the current share price and prospects. The same point can be made about the 2015 AGM here.

In my view we will see a deal here in the next 1-12 weeks. Probably a partnership deal. Look at the evidence. BioNTech (who didn't need the cash for Phase 1) started looking for a vaccine in January 2020. They verbally agreed the Pfizer partnership in March 2020, just two months later, and formalised it the following month in April 2020. Or the Oxford Vaccine who through Vaccitech developed the drug at the same time as BioNTech. Vaccitech went into Phase 1 in April 2020 and did the AstraZeneca deal the following week. We will see something very rapid here, to match Scancell's comment that they will be in clinical trials "very soon". A very rapid deal on Covidity. Bear in mind that the amount of work to go from Phase 1 to Phase 2/3 will be immense, in terms of manufacturing, ethics approval, patient recruitment decisions etc. Scancell aren't just going to get to the end of Phase 1 and then start touting for a partnership. Every potential partner will have their own different systems, locations, strategies, plans and resources that would need to be put into place before the vaccine can get into Phase 2/3. Doing a partnership deal at the end of Phase 1 would only lead to significant delays in bringing the vaccine to market and nobody would want that, not in today's climate where rapid development is needed both globally and commercially. Not Scancell, not those suffering from Covid and not the partner to be. So here is my prediction. Scancell are one of the leaders at the forefront of the second generation of covid vaccines that desperately need to be developed, with a radically new method of action. There are, as said on the presentation today, many drug companies who missed out on the first generation vaccines who will be pounding at the door desperate to be in on this. Scancell need a partner asap to make sure that they can progress from Phase 1 to Phase 2/3 this year. A deal will be done and it will be done soon. The share price will then be nowhere near current levels. No certainties of course and DYOR, but this is my strongly held view. And fortunately, this is just a side product for Scancell (soon not to be) , so there is very good residual value if I am wrong and if things don't go as I expect.

Hi miavoce, good to see you here too.

Hi Bermuda, thanks and good to see you here too. I have taken a decent position and look forward to the journey. Best wishes, SK

hTTps://www.ft.com/content/b8ad59ad-4ecf-4df8-a981-c52b6b848fa0

Moderna expects $18.4bn from Covid vaccine deals this year

"The Boston-based biotech’s coronavirus vaccine revenue forecast is far higher than the $11.2bn that analysts had predicted for 2021, as well as the $15bn that Pfizer said it expected when it reported earnings this month.

Moderna said this number could rise because it was in discussions with governments about more vaccine orders for 2021 and 2022, as well as Covax, the vaccination programme for the developing world."

Given that SCLP is already at the manufacturing stage of a second generation vaccine, with clinical trials expected to be launched "very soon", the market cap here is vastly undervalued.

What it does do is give a big hint that they think the share price will likely not fall from here. Otherwise they would have awarded themselves options later and at a lower strike price.