Member Info for RayPointer

I think I'd be happy with an 8 billion deal LOL

Another link

https://www.ccn.com/2019s-2nd-largest-deal-eli-lilly-to-buy-loxo-oncology-for-8-billion/

"The healthcare market is one to watch for investors in 2019. It’s one CNBC’s Jim Cramer is watching after the Celgene deal. The Nasdaq healthcare index is up nearly 5% on opening today."

https://www.raps.org/news-and-articles/news-articles/2019/1/government-shutdown-continues-as-gottlieb-clarifie

If I'm reading this correctly, INDs submitted before the shutdown and for which no further fee is required are OK but the FDA is not accepting new INDs.

Gottlieb added Wednesday that FDA is still able use carry over funding to hold preapproval discussions with sponsors and accept submissions for which no fee is required such as investigational new drug (IND) applications and supplements to new drug applications (NDAs) and biologics license applications (BLAs) that qualify for fee exemptions.

"However, FDA is only able to perform user fee-funded activities using carry over user fee balances and is unable to accept new user fees assessed in the current fiscal year until new appropriations or a Continuing Resolution is passed."

"For drug and device makers that had planned to submit applications at the start of the year, the shutdown could lead to delays in FDA decision-making."

I can vouch for the 09:35 being a buy LOL

It's all makes for an exciting 18 months.
I hope Oxford airport will be able to cope with all those company jets LOL

Perhaps Lilly will get interested at some point since they are already in collaboration with BionTech on TCR technology.

Yes understood.
So, if the Modi1 trial is successful, it looks like Scancell is holding the strongest possible hand.
I assume by this time the deal with Biontech will have already been done.

Yes, I understand.

But I see no reason why information about the Scancell Collaboration cannot be talked about with Biontech's customers as long as they stick to information that is in the public domain.

Yes, that's why I said broad outline.
We all know what the collaboration is about. What we don't know is how the ideas of Lindy and/or Ugur have increased the scope of the collaboration.
The same with PBP.

I'm saying Biontech's lifeblood is the deals they do to perform research for major pharma.

If they feel they are really part of something with great potential (i.e. PBP and the Scancell collaboration) why would they not at least give an outline of those 2 projects to their major customers.

Maybe not the detail but a broad outline. After all its on their website.

That's sounds logical to me inan.

Why wouldn't they tell all their major customers in the cancer arena.
No reason to keep it secret.

Good point Chester. This is particularly the case with Ugur Sahin. He is CEO of a company planning an IPO at some point in the not too distant future.

Biontech have the TCR technology but they simply do not have the targets; this is what Moditope brings. They can't use the same targets because their use in cancer treatment is under patent.
As mentioned several times before, you can't help feeling that this project will happen GC win or not.

Exactly Rats. What PBP is aiming to achieve is so much higher than the other contestants IMO.
The science is already there and now needs to be proved.

Most of the other entrants are about collecting data/statistics about cancer to increase knowledge about the causes of cancer. That is not to say that the extra knowledge and clever software analysing the data will not lead to breakthroughs.

It's just that PBP is so much more definite about the aims of the project. And don't forget that PBP will also have a data/analysis/software arm to it. You get this as well as Modi3.

But I approached the chances of Scancell winning the GC by comparing the other contestants' projects with PBP.
I concluded that Scancell's entry was at a markedly higher level than any of the other entrants.
All IMO.

http://www.lse.co.uk/share-regulatory-news.asp?shareprice=SCLP&ArticleCode=dbjhgtxp&ArticleHeadline=Investor_Update_Agenda

This links Christian Ottensmeier with Scancell as early as 2013. I would imagine the relationship goes back even earlier as Christian is based in Southampton. One of the SCIB1's trial sites was in Southampton.

Morning Chester.
Yes, my comment was "tongue in cheek" as you suggest.
But, I'm definitely on the same page as you about the GC outcome.

You could also add the comments of the CRUK project manager of the SCIB2 trial Nigel Blackburn. I can't remember the exact wording but he was obviously keen to get Scancell's science approved.

I also recall that Christian Ottensmeier was batting for Scancell in one of Calculus's investment events a number of years ago.

ATB

Yes, in many ways its a catch-22 situation.
I assume a 200-patient trial would have required a partner. VAL just didn't have the money to run a trial of that size on their own.
The regulatory authorities also like small trials to start with to prove safety.

Obtaining a partner would have been much more difficult without any clinical data.

Don't get me wrong. I think the 7 patient trial shows merit. It would have been much better if there were the order of 20 patients. Much more statistically significant.

ATB

Isleworth

I agree that 401 has something about it.
I was actually questioning the statistical significance of such a small number of patients. This is what a potential phase 3 partner would do.

Best of luck with your investment.

Well

Lindy was polishing her sideboard ready for the Nobel prize

RG was practising his polite Chinese bowing technique in front of the mirror

CH was improving his German ready for negotiations with BionTech. He was seen down his local repeatedly shouting "More bitte" to a bemused barman. He ended up with 20 pints of bitter in front of him.

Sally was doing arm exercises down at the gym. She is determined to be able to deliver her next toxicology report in person

TCell the company cat was receiving counselling. He hasn't caught a mouse all year

The mice were madly buying Scancell shares. Then you had the odd escapee making a run for Ladbrokes to place a bet on the GC result

The randomisation is important since it removes any bias in choosing the patients that receive the new treatment

Incidentally in the example I quoted the median expected survival is 5.3 months according to this study

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4316142/

Other studies may give a different answer but they will all be of the same order.

Here is some information as to why Phase 3 trials are necessary (plus a link to info about randomised trials)

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-clinical-trials-are/phases-of-clinical-trials#phase3