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Motif Bio Share Chat (MTFB)



Share Price: 41.25Bid: 41.25Ask: 41.75Change: 0.00 (0.00%)No Movement on Motif Bio
Spread: 0.50Spread as %: 1.21%Open: 40.75High: 41.75Low: 40.25Yesterday’s Close: 41.25


Share Discussion for Motif Bio


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SirTradealot
Posts: 144
Off Topic
Opinion:No Opinion
Price:41.75
FDA approval
Thu 10:55
It's important not to be too glib about drug approval, as noted by jackdaw. There were some issues relating to elevated QT intervals in the Arpida trial. I don't have medical training, but I think the QTc issue was enough of a concern for the FDA panel not to approve the 15% margin of non-inferiority. Now that Motif have done the trials with the FDA's preferred 10% margin, I don't think that (if repeated) would be enough of an issue to prevent approval, but they will consider all factors and not just the "topline" information on which we as investors tend to focus our attention.
 
Mirabeau
Posts: 1,741
Off Topic
Opinion:No Opinion
Price:41.75
RE: gilead
Thu 10:52
OK, Iclaprim should not be approved as it could prove injurious and a danger to anyone unfortunate to be subjected to it. How's that?

let the price do the talking or not, as the case maybe
jackdaw99
Posts: 385
Observation
Opinion:No Opinion
Price:41.75
RE: gilead
Thu 10:47
"what more do the FDA want, blood!" Cast your mind back, if you are that old, to Thalidomide if you really need an answer.
Mirabeau
Posts: 1,741
Off Topic
Opinion:No Opinion
Price:41.00
RE: gilead
Thu 10:42
It's also worth noting that :

'In this trial, called ASSIST-2 (Arpidas Skin and Skin Structure Infection STudies), iclaprim was compared to linezolid, marketed by Pfizer as Zyvox. The pre-specified primary efficacy endpoint of statistical non-inferiority in the clinical cure rate at the Test-Of-Cure (TOC) visit was achieved, confirming the outcome of ASSIST-1 Moreover, iclaprims safety profile demonstrated in ASSIST-1 was confirmed in ASSIST-2. '

FDA rejected iclaprim for various reasons but nevertheless it did compare favourably to linezolid during both clinical trials

all the info is there now for FDA to arrive at a decision..god, what more do the FDA want, blood!
PrivateRyan
Posts: 41
Off Topic
Opinion:No Opinion
Price:41.00
gilead
Thu 10:39
And Motif so far have been underpromising and overdelivering......so the timescale to FDA approval may well be shorter than advertised.But whatever the timescale I am invested for the long haul.....still do not understand how this share has not now rocketed.
UncommonSense
Posts: 168
Off Topic
Opinion:No Opinion
Price:41.00
RE: gilead
Thu 10:31
Yes, the FDA certainly seem to be pushing the boat out to get things done. I'd can't imagine that it will take 6 months for the approval, especially given the size of the two trials, and the safety data presented. I'd surprised is it took longer than 3 months, once all the paperwork is signed off and the application fully completed.

If Motif stay on track to put the application in by March '18 then, June'18 looks like a good month for approval, IMO.
99treble
Posts: 1,212
Off Topic
Opinion:No Opinion
Price:41.00
RE: gilead
Thu 10:26
By Summers end 2018, my view is Iclaprim gets the nod from the FDA, with fasttrack designation.If im really pushing the boat, then an early Christmas present to all shareholders, in the form of a structured licensing deal is inked with big pharma(pending approval).Either way, lots of potential news is upon us to move the SP North.Good day all Motifs.Dave.
Mirabeau
Posts: 1,741
Off Topic
Opinion:No Opinion
Price:41.00
RE: gilead
Thu 10:17
spot on there Pte-Ryan...I reckon the FDA give very important drugs the nod, as it were
Mirabeau
Posts: 1,741
Off Topic
Opinion:No Opinion
Price:41.00
RE: Morning
Thu 10:13
I don't think someone (whoever that may be) chose to publish it at 1am. There's nothing to be gained by doing so. I suspect it's purely administrative oversight or something akin to that.

Mate, trying to understand the reporting of trades is pointless, to a degree. It's a Gordian Knot and it's impossible to unravel

You're either on the inside or you're not...

let volume and price be your guide, and of course company fundamentals!
PrivateRyan
Posts: 41
Off Topic
Opinion:No Opinion
Price:41.00
gilead
Thu 10:12
just on cnbc that the FDA has approved a cancer immunotherapy treatment 7 weeks earlier than they have to .So the six months permitted timescale for approval is not necessarily the time the FDA actually takes.....




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