Member Info for Ivyspivey

No worries,
Really looking to see what headroom May have been asked for in Resolutions 9 and 10.
Does not appear to be asking for a huge extra amount if I understand it correctly.
Appreciate any other thoughts.

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

They also mentioned in results RNS that to do the HABP trial that would likely be with a partner.

Nothing mentioned for next week in Caymans and Justice Kawaley not listed.

https://www.judicial.ky/wp-content/uploads/courts/grand-court/GrandCourtList22ndApril2019(2).pdf

AMR(Anti Microbial Resistance)

https://go.usa.gov/xm4n4

Debruce.
Even Petch accepted that Iclaprim was likely to be Approved so he was as right about that as I and many others here were lol.
His main points always negative were about the performance of the BOD and their salary levels and lack of skin in the game.Views which would attract a lot more support these days including many LTH

Thoth can’t believe you think they would do that.
Firstly the letter was initiated by the FDA so good practice is that they have the prime responsibility to divulge its contents rather than the recipient MTFB.Especially when why would you want to risk upsetting the FDA when they have a pivotal role in your future.
Secondly it will likely contain sensitive info so why would you give this type of info to a potential competitor.
Thirdly.Whatever the information is in the CRL I can guarantee that yes we would have a better idea of the specific issues but would it stop the speculation and all those with agendas from trying to influence the SP up and down.
In fact it would be worse.ATM none of us know what it contains so any speculation is just that.Whereas if we knew more you would have folk on here saying guaranteed Approval and others saying full new phase 3 trials needed whereas we know at least 2 external liver experts will speak on behalf of MTFB at the meeting to their FDA counterparts so the fact that is happening suggests to me that their are persuasive arguments but no guaranteed decisions.
Until the FDA meeting no one can call this but if they had released the CRL I can guarantee there would be plenty claiming they knew for certain so we all make decisions based on our own thoughts and research.
We can off course always wait for the RNS and comment afterwards in the full knowledge that we are likely to be more correct with the benefit of hindsight

Hanibal,Really don’t know who you have spoken to but all my contact with the Company since the CRL and it has been very limited certainly does not suggest they think it is 50/50.
Firstly they have been very circumspect as to what they have said privately or officially and imo would never give any %age probability like you state.
Secondly the words they have used privately and officially are very indicative of a lot of confidence in their position.

I am referring to MTFB itself and not some IR Company and yes of course it does not mean Approval is guaranteed.The CRL is evidence of the fact that MTFB and investor confidence does not always hold sway.
However look at the official evidence and all the references to how unexpected the decision was so hardly likely to be suggesting it is a 50/50 binary bet.
If that was the case think Invesco/SG etc would have sold down to zero which is obviously not the case

Hi Thoth,
You posted a reasonable response so will reply in same vein.
Your article which was in hindsight also published the fact that MTFB states that there were no particular safety issues either cardiac or liver in the Revive trials then and also now.
We know the FDA has raised some liver toxicity issue( the exact nature none of us know) but obviously the Cardiac
issues which were the greater concern in the Assist studies seem to have been mitigated.
So yes there is a divergence of thought between MTFB who state that Iclaprim is not liver toxic and the FDA via the CRL.So we make our choice of how this will work out.
Where we do differ is you think it seems to have been a big con from the start and that is where I totally disagree as do the vast bulk of investors.
Of course the CRL was a big set back but it is so easy to wait for news and then criticise. Even the most vociferous negative folk prior to PDUFA conceded it was likely to be Approved.
Your thoughts on Commercialisation and likely sales we disagree on but that is perfectly feasible to have different views but certainly my thoughts are in line with MTFB which as I say you seem to think is a big con and that I am part of it.
I recall you thinking I was working for the AMP lender.Well plenty on here know me and know what a nonsense that is to suggest that.One I have a full time job within pharma who would certainly not countenance that type of activity and also if you honestly think I would post for 4 years( way before AMP started selling) and have a lot invested here at amuch higher average and then collude with the very people who have led to SP instability then you are truly wrong

Morning Jackdaw,
Good you asked him to provide a link and let us see if he does.
Total lie imo.
The FDA suggested the change to fixed dose in order to maintain efficacy and mitigate safety issues such as QTc which is cardiac and any liver toxicity issues(originally raised by Europe not US).

We can see efficacy and QTc issues are fine as a result of this and other changes.
We know there are FDA request for further liver data.
So Thoth is bringing blatant lies to suit his own agenda.If you are not invested here why does he post here.
To help us from ourselves or to help himself.You decide

Morning ODR
Thought about the YA payment due before the US Court case so FRR must be able to pay that as well as the lawyers or it really is just some desperate ploy to buy more time.
Just wish we would here anything officially from FRR formally if I formally.
Don’t private Company s have to have AGMs as the next one is way overdue and would give us some opportunity for clarification

https://www.courtlistener.com/docket/14933328/frontera-resources-corporation-v-hope/

Also look at the cash burn.It lost 28 % of its workforce or 80 employees.
MTFB has only 8 full time employees and yes some are way overpaid based on 2019 performance.

https://www.benzinga.com/general/biotech/19/04/13537896/achaogens-bankruptcy-filing-proposed-sale-what-you-need-to-know

Don’t miss significance of last poster which highlights previous underestimation of Vancomycin leading to AKI.This enhances the market model of Iclaprim which is obviously dependent on FDA Apprival.

Real-world incidence of vancomycin-associated nephrotoxicity in hospitalised patients with ABSSSI shown to be >3-fold higher than in recent trials

Michael J. Rybak, Pharm.D., MPH, Ph.D., Professor of Pharmacy and Medicine, Director, Anti-Infective Research Laboratory, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University, Detroit, Michigan, USA led a retrospective, cohort study at two medical centers in Detroit from February to June 2018. A total of 82 hospitalised adults treated with vancomycin (=72 hours) for ABSSSI and with =1 baseline acute kidney injury (AKI) risk factors were evaluated. Patients with severe renal impairment or AKI prior to vancomycin treatment were excluded. The study found that the incidence of nephrotoxicity in patients with =1 AKI risk factor was >3-fold higher than in recent trials, underscoring the importance of close monitoring and/or selection of an alternative agent in at-risk ABSSSI patients.

Hi Slider,
The official FDA minutes will not give a decision one way or another merely inform the rest of us what is necessary to rectify the situation by highlighting the exact nature of their concerns and MTFB initial response.
The champagne or tap water will be on ice for a while even if the AGM was held as normal in June.We will be able to assess the confidence levels of the CEO if We attend the AGM something we could not do if the AGM was held as normal

http://phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9NzA1ODA2fENoaWxkSUQ9NDE4MzIwfFR5cGU9MQ==&t=1

Slider know his you feel.
The last AGM was end of June So was expecting the same and IF FDA minutes were negative then not sure we would have gained much by attending .
By having it before then it offers chance to question BOD when they will be well versed with what is required to satisfy FDA having had the meeting.
I value the opportunity to look the BOD in the eyes and ask certain questions before the news hits

Not sure if the FDA give a negative answer then they will still have jobs for 12 months.
I am pleased it is before the official minutes as we can all question the BOD including the value of their Salary’s but much more importantly gauge their thoughts on likely path forward.

Absolutely right Rebarm.
Although these experts will be paid by MTFB they are very unlikely to simply state anything they are not comfortable with or don’t fully believe in as the will value their independence.
At the top level in any profession they will likely all know each other.