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And it is less plain sailing with Ferracru (or doing nothing) for c.1 in 10 people than IV.
“ Treatment-emergent serious adverse events were reported in 12 patients (9%) receiving ferric maltol and 4 (3%) receiving ferric carboxymaltose; none as deemed related to the study treatment. ”
But
“ Ferric maltol was generally well tolerated, with only 10% of patients stopping because of adverse events. The frequency of any TEAEs and treatment-related TEAEs was greater with ferric maltol than with ferric carboxymaltose. In particular, gastrointestinal adverse events were more frequent with oral iron than with IV iron, but the rate with ferric maltol was generally consistent with that reported with placebo in previous phase 3 trials of ferric maltol, with the exception of constipation.”
I get the long term benefit. But the publication today said:
“The aim of the present noninferiority trial was to compare ferric maltol and IV ferric carboxymaltose for the treatment of IDA in patients with IBD in line with usual practice.”
Did they demonstrate non-inferiority? No. But it still worked well and works just as well over 52 weeks. Hence the positive overall recommendation. And sales should still come.
Thought todays RNS was excellent and disappointed with SP falling I first bought in at 54p and in again as SP dropped. I took up the placing offer and topped up again at that price. However as a long term sufferer of IBS which then lead to Diaviticulitus , I have spent may a week on a drip in hospital and the news will offer all that suffer, a way forward and indeed the NHS funds saved on bed time will be huge. I only wish i could had this drug in the early stages on my condition.
This medical problem cannot be understated and SP should fly when take up of the drug starts to have impact.
Comparisons with IV are always difficult and potentially unfair as the way the 2 treatments work is completely different.
IV gives a massive iron dose on day 1 and then if iron levels dip within the test period (usually 52 weeks) they get a top up, so the iron levels of these participants will always be high.
Feraccru (2 tablets a day) builds iron slowly and maintains the level when it has risen so short term it can never compete with IV.
However, as the conclusion states
“Thus, ferric maltol offers a simple, well tolerated and cost-effective long-term treatment solution of chronic IDA [iron-deficiency anaemia] in patients with IBD [inflammatory bowel disease]," concluded lead author, Dr Stephanie Howaldt.
IV will always be required for people will extreme iron deficiency levels, however, Feracrru has 2 fantastic opportunities.
It is much better than the salt based alternatives, however, these are usually given as they are cheap. This will no doubt be the main market.
The other one, which has had little focus is working alongside IV. Once a patient has been given IV they can then be prescribed feraccru to keep their iron levels topped up (something the IV can't do). This will eliminate the need for repeat visits to hospital. Some people need 2 or 3 visits to hospital every year as they can't naturally maintain iron in their bodies.
* 'overbought'
The product is not intended for those who 'need iron badly' - it's not an emergency treatment.
It's difficult to tell if of the comments on here this morning regarding the efficacy of the product or the alleged 'oversold' status of the chart are deliberately disengenuous or ill informed.
Reading the actual report seems to me to make clear that if you need iron badly than you have to go IV - as evidenced by the 1/3 who had to drop of our product. Those 2/3 who stayed on, ie those with a moderate need then our product is just as good and a lot more tolerable and cheaper. I don’t know whether “need” can be predicted in advance.
Teus.
Maybe I should have worded it better. Neutral as in did you expect better or worse.
Neutral news for me is expected news, Positive unexpected to the upside and negative to the downside.
My main concern is that the SP has advanced quickly and is due for a pull back. I'm not knocking the company in the slightest but the charts are indicating a pause and retrace here. I've scaled back accordingly.
If I'm wrong so bet it. I'm not here to rubbish the company !
I'm sorry, there is literally no way you can interpret this study as "neutral". It validates Accrufer/Ferracru to the highest degree possible when treating IDA in patients with IBD. An oral treatment can't claim "non-inferiority" vs an IV treatment as with IV treatment, iron is infused straight into the blood, therefore it works quicker than oral treatments. However, what is important for an oral therapy like this (given all its benefits over IV therapy) is that it demonstrates comparable long-term efficacy vs IV therapy, which it does. This is all that matters. The study is not neutral by any means, it's extremely positive.
Sorry to post my slight negativity , it was just how it read to me. I am very happy for the share price going north.
I reckon it's pretty neutral overall but the stock is overbought at the moment so the market may take this as an opportunity for a bit of pull back.
No problems long term I would have thought
Its a positive message rather than negative
Indeed
last sentence in the report reads
"Thus, ferric maltol offers simple, tolerable, long-term treatment of chronic IDA in patients with IBD"
Hi, no this is not a negative. Shield are not trying for "non-inferiority" vs IV therapy. Being able to claim 'non-inferiority" is a very complex thing in the medical world. Claiming "non-inferiority" is not and never has been in the plans. Shield are just hoping for comparable long-term efficacy, which they are able demonstrate with these studies.
I would take this as slightly negative but shouldn’t affect the share price too much as it’s undervalued currently imho
Today’s RNS seems very positive although I’m not sure whether the “not meeting” the pre-prescribed “non-inferiority” level is a dampener. Does this mean the pill is almost as good as the jab but not quite?!