Member Info for Ivyspivey

IW
Also MTFB had a fee waiver on the NDA and the one submitted for Iclaprim was huge running to several hundred thousand pages

Agree IW.
The prior discussions were amongst the twitter group just to try and “ speculate” on the exact nature of FDA liver toxicity concerns and you were very correct in highlighting some of the Assist conclusions as not understanding why these ALT=AST levels continued to rise.
The Revive data suggests to me that if they all returned to baseline values then the move to fixed dose 80mg and the 40mg for moderately impaired liver patients is even more of a mystery of the FDA concerns.
Should know soon enough and my money would be on a 7am RNS tomorrow or Tuesday but we know they received the CRL late on PDUFA fate(13th Feb) so no guarantees when it will come.
GLA

We have discussed used the White Rose Publication before and you highlight the salient points.
I also asked GL about the relative high %age of IVDUs in the Iclaprim group which he was not worried about.
The importance of this was raised due to the higher number of patients who were not available for follow up as listed in last bit of your posted article.
Thanks for reposting

Morning Jsm.
Think you have answered your own question.It is the lenders decision to sell rather than AMPs so they have adopted a safety first approach selling into the ore news rise on MTFB.
They are hedged to some extent if MTFB rises due to the agreement.
In summary it is about what the lender wants not AMP and no one knows what news wil come next week hopefully

Nothing next week

https://www.judicial.ky/wp-content/uploads/courts/grand-court/GrandCourtList3rdJune2019(1).pdf

I am with JB.
Although I have a lot of experience in pharma I have not been involved with these type of meetings so rely totally on asking the BOD the relevant questions at events like the AGM.
Of course I and everyone else can look at what us published by FDA but what I look for is consistency in terms of what is told to me by the BOD and contributions by those I judge are speaking from a position if authority.
I have to say JBs interpretation of these meetings is entirely consistent to what I was to,d at the AGM

Smalltrader
It was Resolution 9 that they most wanted passed and for some e reason wanted the Major SH in the room hence the rearranged AGM.
Resolution 2 about making a very valid point in remuneration which many suffering SH in here will endorse.

Ordinary Shares
As of 29 May 2019, the Company has 342,491,023 Ordinary Shares on issue. In general, there are no restrictions on the transfer or sale of the Company’s shares. There are no shares held in treasury. Less than 1% of the shares are not in public hands.
Significant ShareholdersShareholdingPercentage
Invesco Perpetual41,816,00012.2
Sand Grove Capital Management39,958,85411.7
Amphion Group16,504,6114.8

Excludes today’s AMP announcement

https://1v6gj215h9gy3y4dgh3it40h-wpengine.netdna-ssl.com/wp-content/uploads/2019/04/Notice-of-Annual-General-Meeting.pdf

Motif Bio plc (AIM/NASDAQ: MTFB), a clinical-stage biopharmaceutical company specialising in developing novel antibiotics, announces that at the Annual General Meeting held earlier today, all but one of the resolutions proposed were duly passed by the shareholders on a poll.



The Board notes that resolution 2, an advisory resolution on the directors' remuneration report, was not passed. The Board is committed to remaining aligned with shareholder interests through its remuneration structures which are in place to recruit and retain talent.



The results of the poll, incorporating the proxy votes lodged in advance of the meeting, will shortly be available on the Company's website at: https://www.motifbio.com/.



The full text of the resolutions may be found in the Notice of the Annual General Meeting, copies of which are available on the Company's website https://www.motifbio.com/ .





For further information please contact:

Morning Goldstink.
My feeling is that they will not release news of the minutes until Monday morning at the earliest.They May know already but likely imo they may get to know later today.
So they will have w/ end to finally craft RNS and arrange Investor Conf Call for Monday if necessary and as you say have key folk at hand at AGM today.
Only a few PIs turned up last week so don’t expect any today which is just to pass Resolutions.
Obviously likes if Invesco/ SG will be there in person but today is about Resolutions and nit anything ekse

Their is a limit( maximum 4 days) but based on how much RNS needs to be crafted( for eg on explaining phase 3 results).
MTFB will have draft RNSs in place covering all eventualities so just need to confirm and sign off.
Imo they will releases news very quickly with the pathway moving forward.They will not release any other news like a capital raise.They will probably give details of a Conference call

That was the time scale quoted by the FDA in the 3rd May Meeting but as I said in my post Bob McCormack responded to the FDA by saying we expect more likely to be 30 days.
So best guess would be Monday( possibly MTFB receive news tomorrow and draft a final response over w/ end. Dont forget a lot of key players are in town for AGM tomorrow.
My main point though is if it does not come as expected then it does not increase the chance of it being bad news as they will not sit on it( CRL came 3pm on Feb 13th) and MTFB convened a Meeting that night.

We can’t be sure about exact nature of liver toxicity concerns raised in CRL but given what we do know it does appear that the assessment of risk of DILI is an important factor.
It would seem that any additional data required to analyse this is best generated by a post Approval surveillance like a phase 4 or by labelling modifications/ analysing previous phase 3 patients on a longer term basis rather than just generating more short course treatment trials.

Benji,
That was one of other points made by GL at AGM about many Approved products for long term use like statins which can often cause serious damage.

As already said DM I wish you a great future.
Not only are there fantastic cardiac surgeons but great heart medications and very safe.
TC

Hi Benjie,
I did ask GL about this at the AGM knowing the answer but his response as to having “ no skin in the game” well I have millions of options so am just as aligned as the SH.
It us just how the US pharma system works re compensation

Nice post Boom.
We are all totally clear where the target market for Iclaprim is that is the standard of care or “ gold standard” but only in a very targeted of ABSSSI patients which is those patients currently receiving Vancomycin who are renally impaired and/ or have more co morbidities like Diabetes or being elderly or obese etc.
Your other points are well made

The other important consideration in this whole“ Approval” process is the Benefit/Risk unless it is clear that the safety concern is such that it would have led to a complete rejection.
Given the desperate need for novel new ABs and some of the subset analysis and comments made by MTFB in 3rd May Meeting like Iclaprim use in diabetic populations will work in their favour.

86 DA
This passage from Executive Summary sums up issue imo

Similarly, there is insufficient assurance based on the limited available data that iclaprim is not hepatotoxic at the recommended dose level. It remains unclear why increase in ALT values develops long after stopping iclaprim despite the observation that in vitro mitochondrial toxicity data on human hepatocytes did not reveal adverse effects. Present limited patient database and analyses do not allow identification of patients (with normal or slightly increased LFT values at baseline) with increased risk for liver function test elevations in order to include targeted precautions in the SmPC for such patients. Although, in the light of present limited patient database a risk factor analysis (e.g. patients with underlying conditions, concomitant medications) is not expected to generate conclusive findings the applicant should conduct risk factor analysis with the available data collected in clinical programme in order to identify patients with increased risk for liver function test elevations.
Overall, the provided response of the applicant to CHMP Day 120 List of Questions does not change the earlier conclusion of the CHMP that on the basis of available data, the major cardiac and hepatic concerns outweigh the questioned benefit whereas there is no sufficient clinical evidence provided that Mersarex is beneficial in special patient groups failing other antibiotics or intolerant to standard antibiotics used in the treatment of cSSTI.

So the dose rate has changed and it is clear from CRL that despite these increased patient numbers there are still some questions re liver toxicity.

What you have to ask yourself is are additional phase 3 type trials going to make this situation any clearer.I don’t think so more likely it is about additional data re subsets or a “ continuation” of those trial patients on a longer term basis.

Re the 3 likely options.It is only one and two which are likely to provide these type of answers rather than number 3( the requirement of large scale additional trials).