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It is easy to grab a pdf, read it and move on. My question is who was the pdf created for, and when did they read it? We are perfectly inside the eye of the storm. Seems odd to rejig info again while everyone is just waiting for the response.
Interesting.
thanks ivy.thats very clear.appreciated.
Morning
As you say nothing really new apart from maybe for focus on diabetes subset,New slide on numbers etc who have renal impairment.
The 40mg dose or half if normal has always been indicated fir patients with moderate hepatic( liver) impairment so is not new
thank you.i expected nothing less.
very interesting question Sterol.hope someone can answer.
Thanks Ivy
Has dose changed on this for patients with hepatic impairment or was it there previously? See it's 40mg but i'd not noticed previously - maybe as it wasn't on the radar
Nothing new it seems? They still emphasize no clinically significant difference in liver enzymes between Iclaprim and vancomycin so I still can’t understand what the problem is. Why does it take 30 days to send out minutes of a meeting? I am the company secretary for a large private company and I send out the minutes of board meetings the next day so I don’t forget what was said and agreed, and to give the board members a chance to review the minutes so they don’t forget what was said and agreed! Bl00dy bureaucrats!
It isn't risky if you wait for the outcome of the FDA minutes and then take a position or not depending on what the FDA demand from MTFB. If the FDA recommends Motif a simple label change then the price will rocket. if the FDA demand more trials the price will get hammered..it really is that simple
any course of action that will cost a lot of cash and extends the timeline to FDA approval will crush the price
Investors held before FDA approval and were burnt, heavily. Don't make the same mistake again
Does anyone know if FDA gave any indication of timescale for turn around of minutes from 3rd May meeting?
I'm very wary of the analyst featured in today's podcast in October he said approval was as good as a slam dunk he never once gave the opinion that there would any issues now today he describes investing in Motif as " very risky" while I don't agree with everything Scot or whoever he is says some of his points do give a balance to where things stand and his critisim of the CEO does hold some merit
Sounds very positive and hoping for option 4 which is a label change.
good find Ian B thanks. I,nteresting positive interview . Which of the 4 options will it be. Hopefully a label change, time as ever, will tell!
Mtfb featured today. 17 mins in.
https://audioboom.com/posts/7256254-chariot-oil-gas-vadim-alexandre-on-motif-bio-plus-chris-bailey-on-bt-superdry-and-barratt-dev
I'm no fan of Lumsden, and I'm on record as saying so since fiasco of US IPO. However that is my genuine belief as is my faith in the science underpinning future success of Iclaprim. No games here just my take on GL...
Again Petch you have let yourself be seen, there has only been one person with a personal grudge against Lumsden. It is also obvious that you already have another forum account ready to jump to ! You really take everyone as an idiot !
Scott, I don’t want to judge you unfairly as I don’t know your personal circumstances but can I respectfully ask you only post when you have something of substance to say & avoid your repetitious and baseless posts.
The success of this company will certainly not rely on views expressed on a forum so I am not asking because I am an investor but just pumping out negativity can’t be good for your soul and is tiresome to sift through.
If you want to trade I could suggest a hundred companies with more potential & which don’t have life saving products, so you could make money and not have to hate yourself in the process.
Yes, MTFB are going into this with the strongest hand they can. If they fail it won't be through lack of trying. It is going to be rather exciting, whatever happens.
(Filtering out spam posts from you know who!)
They have a deal in the background in my judgement As soon as we get approval it will be announced That is why no recruitment. That is why no fund raise. An upfront licence fee will mean no further dilution. That is what I believe and why I have added. Hope I am right
Is that Steve Jobs pre or post life extinction? Makes a big difference.
liver issue, regardless of CRL, enzyme activity returns to pre treatment levels post treatment. At worst its a data oversight and/or labelling matter. To my limited knowledge all "chemical" compounds drawn into the body result in some liver response. The issue is which compounds result in severe overreaction and permanent damage. Iclaprim has been PROVEN by clinical trialling to be safe. End...
They were clearly short of money in Feb without any contingency and it's not much different now. They're now valued at about £30m and about £115m in February but in terms of progress, clearly not share price, which was my point, they're further on, having ticked off efficacy with just liver toxicity to get cleared.
I totally agree that MTFB is not better off now than before the14th Feb. just look at the share price. But I take umbridge with your penultimate sentence.......The more the SP drifts the more likely you are to buy back in and go ramp tastic.
IMO they're in a better position now than they were at 40p+ going into the Feb review. Now just focusing on one issue (?) - more testing/trials or labeling solution to resolve or (qualified) approval? From what's happened so far, it doesn't seem like an outright rejection is an option at this stage for the FDA. Just costs for additional data to be deducted from the approval value.
A rejection could surely only come after supplying any additional data, which didn't meet their criteria for acceptance (unlikely after Lamellar jv), but symptoms of a serious liver toxicity problem would have been obvious before now even if measurements/data weren't sufficient. AIMH(non-medical)O.
Could be due to wider market concerns and nothing related to MTFB specific as nothing changed since yday when it was 9.3p
Bloody trump and it's trade war is effecting every sector.
W.r.t MTFB from Monday next week, we need to keep our eyes wide open as RNS can land anytime.