Scancell Share Discussion Threads

[inanaco] 13/8/2017 14:29

The debate was about Off label

because you debated from the approval stand point when the debate should have been about off label use ... you then closed it down with a dismissal because we are not at that point ...

if you had of just said, well lets see what happens ...

it would have been acceptable ending ...


but posting "it really does not matter" is saying the entire discussion was a waste of time ... which you was party to ...

[bermudashorts] 13/8/2017 14:07

thought you wanted good interesting discussions .......

What do you mean by that?

There was a reason for my first things first comment - was trying to be subtle but wasted I see.

[inanaco] 13/8/2017 13:52

off label is not approval .........

that is the point

funny how a suggestion turns into "it really does not matter"

thought you wanted good interesting discussions .......

[bermudashorts] 13/8/2017 13:51

FDA don't just approve something 'as a drug' - they will specify for which indications and for what stage within that indication and whether as first or second line treatment.

[bermudashorts] 13/8/2017 13:48

They aren't going to approve based on a non-controlled trial with 20 resected patients!

It really doesn't matter anyway - first things first. Getting approved in combination setting is the first hurdle.

[inanaco] 13/8/2017 13:45

i will try again ........

Combination trial

prescribed treatment of SCIB1 will be based on exactly the same regime as the phase 2 adjuvant and late stage trial at 8mg which has just been completed.

keytruda will be also given at its prescribed dosage

both treatments are independent and only work in synergy at the cancer

thus SCIB1 will be approved as a drug ...

so in effect


Why might an approved drug be used for an unapproved use?

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.

[inanaco] 13/8/2017 13:37

But they had no data in that setting ........

i did point out we already have the data set !! your not comparing like for like

[bermudashorts] 13/8/2017 13:32

Terror - do you have link please for that c&P

UK are poor at commercialising IP - very frustrating


Inanaco

No they don't. They will only approve as a monotherapy in the adjuvant setting when Scancell provide the evidence via a late stage clinical (randomised) trial that it is more effective than other adjuvant therapies.

If you follow your logic then Merck and BMS wouldn't needed to have carried out those huge phase III trials in the adjuvant setting because they'd already been approved by the FDA for late stage patients.

[inanaco] 13/8/2017 13:22

Off label as an adjuvant to surgery, not as a combo with PD1

the point i am making is the FDA has to approve SCIB1 because its a treatment that works as a standalone ...

The PD1 works as a standalone

ie that are not injected at the same time completely different regime


the synergy is at the cancer only

[terror] 13/8/2017 13:19

Alan Aubrey, chief executive of IP Group, which backs university spin-outs including Tissue Regenix, bemoaned the fact that even though UK scientists came up with many of the discoveries that have shaped our lives – including DNA, ultrasound, MRI, LCD and fibre optic cable – Britain has been poor at commercialisation. "The UK produces 5% of the world's scientific research output with less than 1% of the world's population. But over the last 100 years the UK has been less good at building an industry across its inventions."

More than a third – 29 companies – of the listed biotech sector have gone bust since 2008 and 10 are on the brink, according to work by Paul Cuddon at analysts Peel Hunt. Another 38 are "fine" and six were bought by other companies.

Experts have declared the death of the 'binary biotech' – early-stage drug discovery firms, without a revenue stream, that have a binary outcome – an all-or-nothing approach. If the first drug that enters clinical trials is successful, the company moves on to raise more money or partners up with a large pharma company; however if the first product fails, it is quite likely that the company will run out of money.

Investors are not stupid – they want companies that have several shots on goal and have good management, a good strategy and a punchy business plan. Scancell are lacking in 3 of the 4.

[inanaco] 13/8/2017 13:14

we already know that treating the adjuvant patient or late stage patient with SCib1 is identical

[bermudashorts] 13/8/2017 13:14

Not really because FDA would only approve for use as a combination treatment.

Still confused about this off label use in the adjuvant setting - are you suggesting off label prescribing as a mono or combo treatment as adjuvant therapy?

[inanaco] 13/8/2017 13:07

the treatment regime for PD1 and Scib1 are not in step ... ie would be given together, at the same time. so its not a true combination forming a single entity its in effect its two treatments given at the same time..

does that make sense ?

[inanaco] 13/8/2017 13:00

I did say i was not sure how it would work but ...

yes, because keytruda is already approved, you would only need to approve SCib1 to be used with keytruda.

[bermudashorts] 13/8/2017 12:57

Inanaco

You're suggesting that approval for combination treatment for late stage patients would lead to off label prescribing for mono adjuvant therapy?

[inanaco] 13/8/2017 12:32

Now lets say Scancell achieved approval for the Combo ... not sure exactly how this would work, but the data set for Mono SCib1 could allow it to be used in the adjuvant setting

Why might an approved drug be used for an unapproved use?

From the FDA perspective, once the FDA approves a drug, healthcare providers generally may prescribe the drug for an unapproved use when they judge that it is medically appropriate for their patient.
You may be asking yourself why your healthcare provider would want to prescribe a drug to treat a disease or medical condition that the drug is not approved for. One reason is that there might not be an approved drug to treat your disease or medical condition. Another is that you may have tried all approved treatments without seeing any benefits. In situations like these, you and your healthcare provider may talk about using an approved drug for an unapproved use to treat your disease or medical condition.

[inanaco] 13/8/2017 12:24

Because PD1 approvals are still limited ... ie the majority are still going through primary trials as a mono, the competition is still in its infancy, and the chosen partner Drug can only be from the approved list unless you can get an arrangement with a phase 2 asset.

[inanaco] 13/8/2017 12:17

Wigwammer

Its actually easy to value, the issue is finding the right partner that has a slot open to expand it .. Don't forget Big Pharma is running hundreds of trials in PD1 with so many vaccine failures they may consider it a low priority at this stage, because so many combo's are still in trial. So if you want to get noticed ...

you run your own Combo trial ..

[wigwammer] 13/8/2017 12:08

Bang on, bs.It's an early stage biotech. It is hard to value. Sentiment is key to valuation.I watch the growing despondency and disarray with great interest.

[inanaco] 13/8/2017 12:05

IMHO
Scancell cannot be forced into administration its has no liabilities with that sort of power,

worst case, scancell put itself up for sale using the normal market method with the share price as the basis of the sale rather than the IP which would then get valued by any bidders.

hxxp://citywire.co.uk/new-model-adviser/news/aim-listed-national-ifa-puts-itself-up-for-sale/a1005620

[bermudashorts] 13/8/2017 11:55

Terror,

1)Would be good if you could answer my 10198

2)I can understand many of the posts on here re. funding, frustration with RG etc. etc. Less understandable from those who aren't invested but what I just can't fathom out is a deliberate attempt to scaremonger and cause panic, especially given the field the Company are operating in. Why on earth would you make this statement?:-

"The worst case scenario is possible with funding impossible to raise, leaving PIs with worthless shares."

Take a look at Redx Pharma - forced into administration and so forced to sell off a PRECLINICAL asset at fire sale prices for $40m. So that's preclinical for one candidate. Are you seriously suggesting that two platform technologies have no value whatsoever?

If you're going to put so much time and energy bashing a stock you don't even hold then at least make it a bit more realistic.

[terror] 13/8/2017 11:26

Scabcell investors face heavy dilution from the next wave of fund raising to support the clinical trials.

The worst case scenario is possible with funding impossible to raise, leaving PIs with worthless shares.

These are the significant risks facing PIs as they grapple with huge losses. Averaging down and looking for short term bounces is a mugs game. Yes, there might be the odd 10% here and there but the timing is too difficult to get right.

The downward spiral will continue, this was not caused by Helium but by Goodfellow failing to have a strategy, promising a sale or deal and delivering nothing. That is the real reason for the share price decline.

It looks like Chips has been unable to deliver anything substantial from America. The company has increased its cost base and generated no added value.

Scancell needs to deliver value, Goodfellow looks incapable of doing that.

[the real lozan] 12/8/2017 21:53

The 'desert wanderers' from LSd,the original home of BUY, BUY, BUY trHYPE, who, by twisting and blaming everyone ELSE for THEIR repeatedly being PROVEN to be WRONG... share the 'knack', as will now surely be 'evidenced again here... of turning losses into LOSSES