Member Info for mannnan

Motif Bio Plc (LON:MTFB, NASDAQ:MFTB) said it has requested a meeting with the Food & Drug Administration after the US watchdog said it wouldn’t be giving the regulatory green light to the company’s antibiotic, iclaprim.

In what’s called a complete response letter, the FDA indicated additional data would be required “to further evaluate the risk for liver toxicity” before granting approval.

–– ADVERTISEMENT ––

Motif, which developed the treatment for acute bacterial skin and skin structure infections, said it is keen to “to discuss potential options to address the deficiencies”. According to chief executive Graham Lumsden, his team may have to wait between 30-45 days before having the opportunity to do so.

"We look forward to working with the agency to discuss options to advance iclaprim towards approval," he said.

exactly this is what i can see delayed no rejected

https://www.proactiveinvestors.co.uk/companies/news/214611/motif-bio-seeks-talks-with-fda-after-iclaprim-setback-214611.html

can,t believe this came down as low as 0.225

and cakes

look like tomorrow back to where it was before that holding rns

up

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.

thanks orslega ...in that case will have another top up soon .great price just need to buy and hold ...easy rise coming soon

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).

Who is he?

3 holding rns yesterday at the same time they scared the people

Recovering

The full ask

Coming before close

1.89. Paid

Mrcalm how much up?

And tick up

another holding