Member Info for Ivyspivey

IW
Not surprisingly agree with all of your points lol

Including the lack of a contingency plan prior to the CRL being issued in terms of raising funds.Knowing the BOD attitude this was a big surprise to me.

As for JG I know he has been intending to stand down for a while to allow him to resume his other life and this was always an interim position.The issue if a permanent FD was more about getting the right person to commercialise Iclaprim.The CRL has obviously effected this aim.

Even though I have an MBA as well it in no way qualifies you to be a FD lol.

Calamari- you say with a 50/50 binary bet thus equates to an SP of say 26p a big uplift from here so it is all about odds moving forward.

So consider this the CRL did not mention efficacy/and other safety issues such as QTc which was an issue last time or any CMC issues.So the liver toxicity is the only issue at hand.

You have seen from previous posts the FDA has Approved many products suspected of causing DILI.

Both internal and external experts appear to have validated that there is nothing in the phase 3 trials to cause undue concern over causing permanent liver damage.

Would MTFB be able to raise more money if there were serious concerns expressed in the CRL re liver toxicity.Hardly their strategy would be totally different if they believed there was a major chsnce of not getting Approval.

I am not trying to underestimate the dramatic fall in the SP here or the potential delay to the process moving forward but I do believe that the evidence so far and despite the radio silence which again I have been critical of then I do think there will be clues as to the way forward and the prospects of the ultimate outcome here.

Calamari,
In the context of the issued CRL,I would say it is positive news.
We don’t know the detail of the FDA liver concerns as none of us apart from MTFB has access to the CRL.
If they were that concerned why do you think MTFB are still pursuing a pathway forward.
MTFB submit all the available data to support the NDA,the FDA ask questions and MTFB answer those questions.If the FDA have more questions but run out of time they have to issue a CRL.

It does not mean they have rejected Iclaprim.They simply may require further discussion and clarification on specific labelling or post marketing surveillance.

It us about interpreting the evidence as it becomes available and I am getting more confidence as this moves forward.

You have your view I have mine.Time of course will tell us who is proved right.I of course have been here from the start whilst folk like yourself turn up and disappear just as quickly.

Of course there are still risks here but do you really think that all the major SH( apart from day of CRL and distressed AMP) have not sold any since the news and they will have a much clearer picture of MTFB plans moving forward.

Do you seriously think that MTFB can get any capital raise without support of likes of Invesco/M&G/SG underway and we know they need funds soon so presume they share MTFB confidence in moving this forward.

Calamari-of course they would no about the potential for the potential for the FDA to raise liver toxicity concerns given the FDA focus and it being one of the previous areas of doubt.The FDA review questions would have included “ liver toxicity” questions so again MTFB would be aware of the possibility of further analysis.
They would have hired the external liver specialists in preparation for the Add Comm which never came.A sensible and prudent move.
The CRL is part of an Approval process not a rejection as you insinuate but a definite hold on proceedings until further clarification becomes necessary.
What you have to ask yourself is whether this issue is likely one that MTFB feel they can overcome.If the independent external experts are supportive of MTFB position which they are likely to be if MTFB was prepared to use their views/ opinions in a possible Add Comm setting or supportive of the FDA position.
My point is if it was a major concern their expert opinion is unlikely be be divided.
However if it is about a labelling issue or imo about trying to predict the wider DILI risk from the available evidence which we know is extremely difficult to get a complete consensus on then the use of experts to argue the case is a sensible move.
The FDA will have looked at the MTFB response but have not rejected this but may simply require more information or discussion due to the shutdown.
In an Add Comm they would discuss these matters fully and make a decision and in the absence of one they may need further discussion.That is what will happen at the forthcoming meeting.
The default position is a CRL so it is a bit like any complex negotiation( hate to mention Brexit) where the PDUFA date us a fixed deadline and the CRL is the default.
It is clear that MTFB are confident in their position and they know the detail so again you need to ask do you think it is an issue than can be overcome and their is a pathway forward.

Listening to conference call again I think the package which accompany the meeting request was hoping to be submitted by 22nd Feb so you are correct in taking your timeline from there

Sorry it is DILI.
Yes as it is a short term treatment it will reduce risk of liver injury.
The point I am trying to make but may be unclear is if it is a short term treatment it is more difficult to use any results such as elevated AST or ALT levels to act as prognostic indicators for DILI as part of a much wider population which us what I think is the additional data or clarification required by the FDA.
If it was a longer term treatment like a NSAID or Ace Inhibitor etc then these results would be much more indicative of a wider issue.Diesvthat make sense.

Hi Flakey
Do you mean that transport company and feed mill based at Wardle.
Agree with all you say and GL

https://www.fda.gov/downloads/ScienceResearch/BioinformaticsTools/LiverToxicityKnowledgeBase/UCM606243.xls

Appreciate your input and still think it is not about the raised enzyme levels encountered in the trials per se but in the evaluation of how much these biomarkers are prognostic indicators of DIKI(Drug Induced Liver Injury) in a wider population which we know is a major focus of FDA.
Do you have any thoughts on evaluating this risk in short term therapy’s like ABs ie Iclaprim as opposed to many of the long term use of NSAIDs and other long term medications on yours and the attached list.

https://www.judicial.ky/wp-content/uploads/courts/grand-court/GrandCourtList18thMarch2019(1).pdf

As anticipated no mention of FRR.

Hi Fkskey
You dabbers or can’t remember if you are a potter know how to live life with Bongos Bingo.
Let us hope your Bingo pen was lucky.
As you say we have to suffer the silence and wait and although the Court documents are positive for FRR we can’t be sure how this will play out.
However much happier with this being delisted as can you imagine the ups and downs if we were still listed so a must being patient and see if you are going Boom or bust lol

Hi IW
The decision to average down or not for LTH is an individual one based on how many shares,their current average,how they view risk/ reward moving forwardetc.
Many are probably over exposed here and in view of the shake to their confidence based on the CRL they may well feel reluctant to add a lot more to “ average down”.
However,if you detach yourself from any feelings of I as a LTH who have essentially taken all the risk and am currently heavily underwater and accept the current reality then I fully understand why it makes a lot of sense to add at these levels.
Personally my view is most of the LTH know the fundamentals here very well and are very capable of assessing the risk moving forward.For myself I am waiting for a clue or news before adding in any meaningful way and yes may buy a few at these levels to trade a few and if stuck with them no matter.
However if I only had a small exposure here I would be certainly buying in heavily at these prices but the AMP seller is still about and until we here news this will be volatile as many games being played.
ATB

Hi IW
Responding to your questions imo and only wish I had your average rather than as a LTH but wish everyone well short or LTH as everyone gains to a greater or lesser extent.
1.Very little risk considering me and many institutions were quite happy to pay at 6-9x these levels.
2.The inherent value in a fire sale is way above current mkt cap.
3.Very low risk.The issue seems to be the elevated AST and ALT levels and how this can be extrapolated to serious liver toxicity issues in a much wider population.Any concerns will not be resolved with an extensive trial expansion.
4.Will be resubmitted well within a year.
Yes there are risks like we don’t know full FDA concerns and question of dilution but in balance a fantastic risk reward at these leveks imo but many LTH have much higher averages and hence their risk reward is more measured.
GLA

Not sure if it is about the 40mg dose.
Still feel it is about assessing the raised ALT and AST levels and extrapolating the risk of liver damage in a wider context from the available data.
These prognostic indicators are open to interpretation and discussion and that is what will hopefully be clarified at the FDA Meeting

Think the lawyers used by aHope and Outrider were originally used by FRR in other cases so they changed to Moutant but in the documents I think Hope is using another firm

Clear the judge has conceded that although he robustly rejected the case against Hope and he has not changed his mind based on the initial evidence then he states that the Appeal has a reasonable chance of success so something has changed and can only think that us due to new evidence from the discovery.
The fact that he has banged the heads together to seek an OOC commercial rather than a judicial settlement would fit in with this notion of neither party having a conclusive case and therefore more likely to setlle

Don’t forget US volume is in ADSs which are equivalent to 20 AUM shares so volume is equivalent of 1.6m so pretty high

Sorry I only had a quick glance and yes they can sell at any price but just don’t think in their interest to off load at this level.Firstly it would depress price further and they would simply use up their shares quicker and put the whole reoayment at risk( pay back September 2019).Plus they are incentivised above 10p.
Agree not great as it puts pressure on SP which without news will not show lots of volume and aksinjust adds to shenigans here.
Leaves AMP in a real mess and just wish they were out the picture here entirely

Just the AMP lender ensuring it reduces its risk due to perilous cash position if AMP.
Obviously been made much worse by dramatic fall in value here but at least they have to sell above 10p and guess we will need news to take us above that level.
They could have screwed AMP even harder so guess they believe that value here will be achieved at some stage in the future but game in town is getting positive news and that will determine future hereditary

http://cbw.ge/economy/georgias-energy-sector-watch-summary-of-changes/

https://jobs.bp.com/georgia