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4,000,000 shares
Ian, have a read of the Wikipedia entry for iclaprim. To quote from the entry:
A new drug application was rejected due to failure to show non-inferiority and due to safety concerns, especially drug induced QT prolongation. the FDA advisory committee said that the drug ''should not be developed further'' based on the results presented.
Wiki goes on to say that:
application for the drug with the European medicines agency was withdrawn in 2009; in the announcement of the withdrawal, the EMA said that there had been insufficient data from clinical studies to justify the dosage proposed by the company and that resistance to the drug had already been seen in the clinical trial data.
Now, I'm not saying that Wiki entries are gospel truth but I do say that there is no evidence to suggest that they are any more or less true than what you or Ivy or any one else is saying. The references for this particular wiki entry are listed. I wanted to be able to read ref 9 but I cant get it. But have a read of ref11 - interesting - it is about Merserax which I assume Arpidia was going to name the drug for the European market.
If you've read all this stuff already then apologies, I may be behind the curve.
Typo - third para.
Fda did not say that the drug should not be developed further.
(I missed out “not”)
Do you think institutions would have backed this with many £millions if that was the case.
Apologies if any other typos, on phone.
I dont hold amp but do hold motif and have a thorough knowledg of the history of iclaprim. Northerns post is inaccurate
and misleading. Aripida were given guidelines by fda for phase 3 trials of iclaprim. They chose to ignore the guidelines and selected a different comparator drug and dosage.
The fda did not ever say the drug should be developed further!! That is fabricated. They told aropida to go away and re-do the phase 3 trials and follow the fda requirements. -
In its letter to Arpida, the FDA stated the Company's NDA did not demonstrate the efficacy of iclaprim for treatment of cSSSI within an acceptable non-inferiority margin. The FDA requires additional data to assess the benefits and risks of iclaprim for cSSSI.
To address this deficiency, the FDA requests an additional study or studies to demonstrate effectiveness of iclaprim. An additional study showing non-inferiority of iclaprim to an approved comparator may be sufficient to meet this requirement, depending on the study results.
That was the fda advise. No where did it say do not develop the drug. Aripida had screwed up.
The difference this time with motifs NDA is the fda have accepted efficacy and the issue raised is raised liver enzymes in 2-3% of the 1200 patients dosed. The raised liver tox being very similar to the comparator vancomycin which is an approved drug, widely used that also damages kidneys in the renally impaired.
In this crl tto motif fda HAVE NOT requested further trials but requested further data on liver enzymes.
That info given in motif conference call.
on POLX. Looks like good tech, nobody at risk of dying just much improved diagnosis so no "angst" from the "overzealous" FDA and $500m/yr sales. Lots of peeps with lung disease like Asthma, COPD and so on. P3 now
Cant believe anybody would buy this. Huge debts around £25 million and assets of around £7 million maximum. So basic calculations would tell us that its main player Motif needs to reach around 60p or so before this is worth ZERO...LOL
Somebody. Maybe meek himself deleted the posts. I think he felt stupid after thinking he has got in here cheap. Didn’t realise how up the creek amp is.
It seems to me you have a northern explorer forum.
If you believe in Iclaprim you should buy Motif. Motif needs to 10 bag before amp is in positive teritory
Only 300k now. Just letting them ride. This has already moved up for no reason, it could go even further
Its been passed around from company to company for around 10 years now.
According to Motif Bio, iclaprim has an underutilised mechanism of action compared to other antibiotics. The diaminopyrimidine dihydrofolate reductase blocker, was licenced in 2001 from Roche by its spin-out company Arpida, which later merged with Evolva. Arpida ran two Phase III clinical trials for complicated skin and skin structure infections, called ASSIST 1 and 2, that were completed by 2008 but as of 2017 had not been published in the medical literature.
A NDA was filed with the FDA based on these trials and was rejected due to failure to show non-inferiority and due to safety concerns, especially drug-induced QT prolongation. The FDA advisory committee said that the drug "should not be developed further" based on the results presented. A parallel application for marketing approval to the EMA was withdrawn in 2009; in the announcement of the withdrawal, the EMA said that there was insufficient data from clinical studies to justify the dosage proposed by the company and that resistance to the drug had already been seen in the clinical trial data.
Arpida sold off iclaprim to Acino Pharma in November 2009 and the company handed over the rights to to a group called Life Sciences Management Group, Inc., which assigned its rigths to Nuprim. In 2015 Motif BioSciences Inc. and Nuprim merged. In 2017, Motif Bio announced positive results with iclaprim in two Phase III trials (called REVIVE 1 and 2) to show non-inferiority to vancomycin in acute skin and skin structure infection. In September 2017 the FDA granted orphan drug status to iclaprim for the treatment of Staphylococcus aureus lung infections in people with cystic fibrosis.
"should not be developed further" based on the results presented --------that put the last lot off I suppose.
Do you know the full history of Iclaprim meek ?
At 31 December 2018, the Company had cash of $12.3 million and $15 million of debt drawn from its Hercules loan facility. The Company is financed into the second quarter of 2019 but will need to raise capital in the near term.
No director buys, even at this level;
No one wants to be in this dog as the debt is massive, mega dilution coming soon - possible convertible notes or very low primary bid offer;
Motif needs to raise a lot of cash to continue and that cash will be at a very discounted price as the risk is very high now;
Major II'S already reducing their holdings in Motif or getting out completely, if there is no major II'S support then you can forget about anything good to happen!!!
Motif will need soon to issue an RNS of how much cash will need to raise and what huge discount to be offered to convince some major II'S to buy it and share price of AMP will adjust to that, then you will see the final collapse here, Unfortunately in this shit market and with Brexit issues not many willing to invest in this.
The price swings in share price you see now is the herd looking for a quick buck because of high volatility and a small possibility to make some small profit but you already know what is going to happen when the herd gets bored and leaves!!!
https://endpts.com/motif-bios-turnaround-quest-for-once-rejected-antibiotic-hits-the-crl-wall/
Motif will now request a meeting with the FDA, which it hopes could take place within the next 30 to 45 days. But in the meantime it will have to raise new capital as it is only financed into the second quarter of 2019. The update from the FDA also dealt a blow to Motif partner and shareholder Amphion Innovations, whose shares slid 71% today.
I wouldn’t be buying any more anytime soon. Not sure why people are still buying
Guys you both seem to be geniuses on the entry points...I should learn from you....nowhere as good as you two....
What price did you buy in at. Don’t forget to bank profits.
Meek. If I wanted a better buy in I could buy in now at .48. But it’s nowhere near as attractive as it was when the news was due. Could still get good news from Motif.
I bought in just over 1 and sold vast majority in the 1.8s. Bought into Motif just under 6 and sold at 11. Bought back into motif this morning and sold a couple of hours later for 20%. I bought amp on the hope of a leveraged holding in Motif. That was based on motif moving from the then 40p to 120p or more. At which point amp would be starting to use its leverage. Obviously the deal hasn’t gone through. There is still hope. Even if motif were to ten bag at this price. Amp is still in negative territory
Meek. I see you’ve bought in on Twitter ramps. Just don’t be left holding it. Bank profits. I’ve made a decent amount ( could have made more as I sold too early both times ) these shares are rising without substance. Motif needs to reach over £1 before iAmp will be moving into positive territory.
Meek. I could see from the start your new to investing. With the statement about it dropping 75% and the company wouldn’t allow it. Pmsl. Do you actually know how much amp would be worth if they sold all their investments at today’s prices. ? I know you haven’t got a clue.
Rough figures. Assets. And Debt. What do you have
I’ve never told you to sell. Just curious why people are buying. Do you know how much they have in assets like Pol and Motif and the others. As well as how much they owe