George Frangeskides, Chairman at ALBA, explains why the Pilbara Lithium option ‘was too good to miss’. Watch the video here.
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Wipe Out...
bouncing back ..1.8p by closing?
:D
Lose some, lose some even.
0.3. **** me
Can't even trade it on IG
Gonna go in dry too
Sh ite result
A bitt rogering coming up. Bend over lads
-41% opening..lovely..
I thought I had done the wrong thing selling most in the 1.8s thinking this was a done deal. Feel for the lth.
It is pretty bloody bad. Not only will MTFB fall but also be dilution via capital raise... AMP in no position to participate.
GoldGirl wake up love. The FDA won’t look at this for another 6 months at least, on top of which they have now said they need to raise cash (motif) diluting to hell yet again to pay for more tests. Could easily be the end of the road for amp imo Amp will now be in a dangerous position re cash It’s a shambles
hmm .... not sure where the bid is going to come from for this one. Dont have a clear sense of where they go from here. POLX has some value but is going to need more cash and I am not sure it is even close to covering their debts after you take out MTFB.
Disappointing yes but not the end of the world. Just need more dats regarding liver tox.
Seeing as this was amp bog chance to get out of debt. Serious problems now here for amp after motif news
Great. . . Bloodbath coming up
Press release I assume RNS to follow
Not approved more data needed
This report displays final approvals and tentative approvals of original and supplemental applications for the two weeks beginning on the earliest date listed below. Some approvals may be added to the Drugs@FDA database after this timespan. For comprehensive approval reports, please use the monthly "All Approvals" report on Drugs@FDA.
Lets wait for RNS - it may not have been pit on yet
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page Approvals from yesterday but Iclaprim not on there. Slightly nervous now
Yes, all being well coldspy. Good luck all
Saw some of the 12/02/19 one popping up on the FDA website yesterday evening (13th)so I don't think it's live updates.
I'm guessing we'll get a morning RNS 7am
And FDA website will update later in the day. Company will know before FDA website publish it
Good luck all, hoping for a very exciting day ahead
Iclaprim is new antibiotic that targets gram positive bacteria and has had a somewhat unfortunate past, it was originally owned by Aprida who brought the rights for it from Roche back in 2001. Aprida ran two phase III trials with Iclaprim targeting complicated skin and skin structure infections. An NDA was filed with the FDA based on these two trials but Iclaprim was rejected for failing to show inferiority. Whilst it may sound alarming that Iclaprim has previously been rejected by the FDA there were circumstances surrounding the rejection that need to be taken into consideration. Iclaprim is safe and effective and just happened the be in the right place at the wrong time with the previous application. Just before Iclaprim’s previous submission a similar drug which had already been approved was later found to cause severe liver issues the ensuing scandal resulted in a regulatory environment where it was near impossible to get new antibiotics approved.
The regulatory environment has changed significantly since Iclaprim’s first rejection with it now being widely recognized that there is an urgent need for new antibiotics to combat antibiotic resistant bacteria, especially antibiotics with under utilized mechanisms of actions such as Iclaprim’s. With antibiotic resistance seen as potentially one of the biggest threats facing humanity over the coming years new antibiotics are now much more likely to be approved by the FDA. Testament to the change in the regulatory environment towards antibiotics there were three antibiotics which were rejected around the same time as Iclaprim; omadacycline, dalbavancin and dalbavancin. Two of these have since been approved and the third recently submitted a new NDA with the FDA.
An established safety profile: studied in over 1,400 patients and healthy volunteers and no evidence of kidney toxicity in REVIVE Phase 3 trials.
More than 3.6 million patients with ABSSSI are hospitalised annually in the U.S. It is estimated that up to 26% of hospitalised ABSSSI patients have renal impairment. Hospitalised patients with obesity, diabetes and/or poor kidney function are particularly vulnerable to vancomycin-associated kidney injury. Many standard of care Gram-positive antibiotics are not suitable for treatment of hospitalised ABSSSI patients with these conditions due to efficacy and/or safety issues.
The NDA includes data from two Phase 3 trials (REVIVE-1 and REVIVE-2) evaluating iclaprim for the treatment of patients with ABSSSI. In both trials, iclaprim achieved the primary endpoint of non-inferiority (NI) (10% margin) compared to vancomycin, the current standard of care, at the early time point (ETP), 48 to 72 hours after the start of administration of the study drug, in the intent-to-treat (ITT) patient population. Iclaprim also achieved NI (10% margin) at the test of cure endpoint, 7 to 14 days after study drug discontinuation, in the ITT patient population.
Iclaprim has received Qualified Infectious Disease Product (QIDP) designation from the FDA. If iclaprim is approved as a new chemical entity with QIDP designation, it will be eligible for 10 years of market exclusivity in the U.S. starting from the date of approval, under the Generating Antibiotic Incentives Now Act (the GAIN Act).
On the link https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=reportsSearch.process