Member Info for Ivyspivey

Morning
It was mainly for new investors who ask questions about how come it did not get Approval last time.
All the other 3 drugs that were rejected in 2008/9 have since been Approved.
With Iclaprim it is not about just resubmitting the package like with most of other 3 and getting Approval due the transformation in FDA environment due to critical shortage of new ABs.
It is about understanding the changes to protocol,the close cooperation with FDA and the journey that MatafB have been on in a very planned and targeted way since 2014.
I keep going back if you read the Arpida Add Comm feedback it was obvious that they were at loggerheads with a fairly intransigent FDA during the meeting so were very unlikely to get any goodwill.
In addition the safety and efficacy results were just not good enough to overcome these objections hence no surprise they were rejected.
Complete different this time and I know that MTFB and the FDA have worked very closely together

But good background and explains why MTFB think Iclaprim will be a useful addition to the AB armoury.

http://www.evaluate.com/vantage/articles/interview-motif-seizes-antibiotic-renaissance

Just relooked at latest presentation from 8th Jan and noticed two refs on p7 and p13 about use of Iclaprim at 40mg.
The p3 trials are at 80mg so could be interesting say for moderate renal impairment they get a licence for a reduced dose saving money and extending potential market.
Could have been reason for submitting NDA late to get a wider labelling firvIckaorim.we will soon know.

Yes 10 years starts from each indication so ABSSSI but HABP/VABP will be 10 years from when that is Approved.
Also don’t forget extended patent protection until 2037 on Iclaprim.Nasdaq is much more volatile than here

Equally did Hope not seek asset disposal.
Strange yes I know he has debt seniority but what would it be worth if PSA was validated etc

Nice post a Prodigy.
Although the latest e mails are 9 months old and don’t shed any totally new light on subject apart from 97% arbitration figure they add a lot to understanding of the position that FRR were in and more of the reasons why ZM may have been circumspect in releasing info.
It is clear that Uncle Sam in form of Senator Wilson will play an important part in supporting FRR argument with GG.
Also clear that the process re fiduciary duties of Hope started at least 6 months before default which now looks increasingly like a planned move to get rid of Hope and start the commercialisation as time is of the essence.
Don’t know how this will play out but hopeful that good sense will see through

Morning
Think this was the guy listed as being a friend and Senator.Pretty influential

http://agenda.ge/en/news/2018/1953

Think Arbitration is due to resurface in mid 2019 and need the following

CC sorted and NY funding confirmed.
Move on operationally and get the commercial production going to save the PSA.

We are getting a much clearer picture of behind the scenes challenges and way ZM has responded but still lots of hidden stuff and could still go either way

PS the extra trial was requested as ARPIDA chose a different NI margin and comparator drug as soc.

Hi Tobias,
MTFB have made many changes to the trial protocol in consultation with the FDA to ensure a smooth pathway in phase 3 trials.
Last time Arpida chose a different comparator ie Linezolid a different NI margin ie 12.5% to the FDA advice if using Vancomycin at 10% and argued there case which the FDA took exception to.
There were issues with the trial sites and also about 4 deaths and some concerns over raised CTc levels.This was mainly due to Iclaprim dose rate being weight related so there both efficacy and safety issues both raised during the AddComm.
The FDA suggested a fixed 80mg I/v dose to help overcome the CTc issues which MTFB did and has proved right without compromising efficacy.
MTFB made all the appropriate changes and of course the whole AB environment has changed since a Ketek.
That is why we are confident here and think if there were any real concerns they would have had another AdComm which has not happened
ATB

Ian plus SG at 12% or whatever.
Also if you include warrants Invesco are nearly 30%.
Only ever sold a very few to take them belowvthreshold at which they would have to have made a bid sbdvtgst was 2 years ago plus

http://ir.motifbio.com/phoenix.zhtml?c=254416&p=irol-secText&TEXT=aHR0cDovL2FwaS50ZW5rd2l6YXJkLmNvbS9maWxpbmcueG1sP2lwYWdlPTEyNjc2MTE5JkRTRVE9MSZTRVE9JlNRREVTQz1TRUNUSU9OX0JPRFkmZXhwPSZzdWJzaWQ9NTc%3d

Of increase in M&G shareholding to over 9%

No worries.
Top of jumpy head.About 10m trading as MTFBW after US listing and 10m in European placing.Plus about 10m from original AIM listing(9m given to owners of Arpida).
Plus a few for fees etc and have various options for BOD

Jimzi figure us much more accurate and most are in sticky hands

Evening Crumbs,
He gave out his phone number and e mail address.All anyone has to do is contact him so really can’t see it not being him.Not sure what proof anyone else wants.Just ring him if you have any doubts

Trying to help people understand the market does not always move with fundamentals.
For the record MTFB has not been at 65p for about 3 years.
It has risen about 70% from its lows of 25p only a few weeks ago

Should not effect it as all PDUFAs up to 17/2 were confirmed and that was before shutdown temporarily ended

C7
Not disputing they are down hugely over time and that is why I got out.Simply stating I only invest long term in Company’s like here where I am comfortable with the science but accept that you may have to wait an awful long time to get value and there is always risk.
As well as being comfortable on the ride I want to make money as well at the end of the day and can wait.
Just some pontificate on about the science whilst not recognising or understanding how this market works and ackniwledging tgere is always an element of risk

Like most think the science here is far superior to the other share that gets referred to.
However the fact is that one I s +27% and we are down 5%.
If you want to make money it would have been better with your money in there at the start of the day rather than here but obviously if you want to just eluciadate about the science then you can pay a heavy price.
For the record I have not been in Vak for 3 years and am heavily invested here as believe the value here will be reached but simply record these thoughts if being illustrative of how AIM works.
If you only concentrate on the science you are going to have to be proved right to make money and of course there is always risk as we know

https://bit.ly/2F673o0

https://idsa.confex.com/idsa/2018/webprogram/Paper69258.html

This subset analysis from combined Revive 1 and 2 is the type of analysis which I think may have delayed the NDA submission by 2 months in order to validate use of Iclaprim in other situations such as wound infections.

Know Dr Lodise did a lot of work with US veterans and this just adds to e tea bank of knowledge of where a Iclaprim can price a useful addition to treatment regimes