Member Info for dan1nat1

Trace The Batches21 Jun '18If they could trace which batch was used on which patients and could show a batch screw up then the data might actually show that Traumakine worked as expected and real placebo mortality was 32% as expected.

Can't believe this could happen but it would fit in with the reported figures. Super unusually low placebo mortality and traumakine working as expected in exactly one third of 'treated' patients.

18The 6 batch theory fits about exactly.
From 14 June RNS Traumakine when shown to be taken by the patients (biomarkers) results in 14.6% mortality. When not shown in patients mortality is 32.3% as expected.
From 8 May trial results mortality was 26.4% in Traumakine treated patients. Very high. But if only one third were given Traumakine and two thirds placebo then take 14.6 plus 32.3 plus 32.3 and divide by 3 you get an average mortality of ... drum roll .... 26.4.
Could be. Could be. Really hope they can link the batches to individual patients.

Found the posts, originally by Breq

18Super weird. June 14 RNS gives Traumakine working as expected in 48 patients but not in the other 96 patients treated.

Does that mean 3 batches of drugs were used and only one batch was the right formulation/stored right ?

Or,

Mortality in the other 96 patients was exactly as expected as if on placebo at 32%. The placebo arm mortality was actually 23%.

Only way you could easily explain these figures is if they gave 1 batch of Traumakine to treated patients and 2 batches of placebo to treated patients. Placebo patients got 2 batches of Traumakine and 1 batch of placebo.

Did they use a CRO for the trial or do it themselves ? Must have used a CRO. They've never named the CRO.

Have taken modest position on this being an all time batch screw up.

As it is that theory doesn’t work, it does not explain “many of the other results observed from the trial including why Traumakine activity was variable in the INTEREST trial compared to previous studies nor the low mortality of the placebo group.” If a non active version was used it would not have worked on a sub section of patients, also note the low mortality of the placebo group.

Someone posted on here months ago, with an idea in relation to an administration error, that could have been an explanation. I wish I could find it, as the numbers posted did add up to what could explain the error. It basically set out the numbers if a batch of the placebo was mixed up with a batch of the Traumakine...

At least the sale is out of the way now, and maybe we can start some sort of recovery.

They sold there holding...

Well the real bid is ticking up 108.8 now, looks like a shake on low volume to me.

To be honest though anyone that wants to be in for results (trial not financial) should already be in by now, so we are actually looking at the calm before the storm. It will break one way or the other pretty soon.

Last Monday was quite interesting...

Well the real spread is 112.55/113, Peel wont hold the offer this low for long, so we cold be in for some action today!

WildOne, do you know Fundraiser?

Last year they updated the market 2 days before the interim results, nothing to say they will hold back news if they have it ready for release before Thursday.

Close after trial updates is the big one ;) and that might not be Thursday.

From what I’ve read, it’s more a case of when the deals dry up they will cash in. SP at that point...who knows, but it will be interesting to find out.

"Time to go."

Did you go yet?

Your only post on here is telling us you are going...lol.

That’s what they did on Monday and we jumped around 15%...

Drops on low volume, watch for the bounce as soon as a decent buy comes in!

Things happen that are out of people’s hands...is that really goal post moving?

50/50 in that the results will be good of bad yes agreed it’s a yes or no answer. 50/50 odds that the drug will work...not sure how you can work that out? The facts are the drug does work! As stated June 14th -
Sub-group of patients with elevated interferon-beta biomarkers show a reduced mortality

·     This sub-group of patients (n=48) showed a reduced Day 28 (D28) mortality rate of 14.6% compared to 32.3% (p=0.02) in Traumakine treated patients without a defined biomarker response (n=96).

·     The sub-group of patients with a defined biomarker response also demonstrated an increase in ventilator free days to 16 days compared to 6.5 days (p=0.06)

They just need to figure out who to aim it at, and if tweeting it can make the target group bigger.

My other holdings are all dead certs so this one being a gamble is ok... ;)

8th May
“We look forward to the results of the Japanese study in Q3 2018 and will be considering how we can advance Traumakine in clinical development.”

It doesn’t actually say confirmed, but then we are hardly going to get an RNS saying the results are confirmed for x date.