Member Info for Ivyspivey

Petch.
Agree totally about NASDAQ but even you got it wrong about Approval as you predicted it would be given.If the Conference Call reveals anything hidden I may change my mind but ATM we simply do not havevenough detail

Hi Uddinkas,
We do have a private twitter group or if you are on ADVFN they have a nice DM facility whereas I think here you can only DM if you are a Premier Member( May be wrong).
Until we get Conf Call and get some real information that we can then interpret not sure there is a lot to say.Dont think another What’s App group is going to add any meaningful input but if others want it fine.
Totally understand the point re the board now but due to what has happened rather than just one general group of LTH who could disagree and discuss it will divide into two main camps the LTH either new or old investors and a whole plethora of short term traders( who have equal right to be here of course) with different agendas and hence totally different posting styles etc.
Normally happy to try and respond if asked but ATM you just end up going around in circles and it just takes so much time and effort for mostly just to get one liners back asking more questions that we simply don’t know the answers to st this juncture.
GLA

Yep C7.
Whatever our difference GL today but not tonight lol

As long as Sheltie buys me drinks I will keep going to 95 lol.
Yes time spent with family etc is a great distraction and cool heads and calm reflection are essential for getting things in perspective.
Look forward to getting the detailed updates as they come through but hope a start is made soon at least to give us a better indication of how they see things moving forward and the associated timelines.
See what tomorrow brings

Thoth.Balanced post and certainly agree re seeking an extrernal partnership or licensing deal to spread risk especially in very early stages.
Of course as you become a later stage drug development Company like MTFB which ironically has passed the most risky part of its journey ie the phase 3 trials then you have the option of pursuing it themselves until Approval to get the full value deal but of course you take all the risk.
With hindsight a partner would have mitigated most of the risk of what happened on aThursday.The confidence by virtually everyone of a successful Approval decision has obviously been misplaced even if on a temporary basis.
But yes lessons to be learned include level of exposure and derisking before the actual decision day.
ATB

Rebar,
Hope you are well.Excellent post.As MTFB had a fee waiver on their submission and no AddComm and if thecFDA were under severe cost constraints due to the shutdown they would hardly be doing any favours in their NDA.

Mrmineral,
Not sure if your comment is serious but surely if the institutions knew something why would M&G be buying millions of more shares and both them and Invesco selling them at 5p within minutes of the announcement rather than sell them in the run up to PDUFA.
All the LTH share your disappointment and certainly based on the info available this liver issue was not raised beforehand,but positive news will return this to previous levels but I am not underestimating the time it may take,the volatility etc and the risks ahead.
ATM we simply do not have enough information to make informed decisions moving forward.
Personally believe this has been oversold but future trend depends entirely on sentiment,new and trader momentum.

Snark
A question many of us are trying to get our heads around since Thursday.I just wish your wife had appeared on the board earlier and asked it lol.
It is my wife’s birthday today so not quite the celebration I had planned.
Ribsbly have to work until I am 90 now.Sorry but of gallows humour

Morning Kelsbells/Ian
Still licking wounds a bit and until we get some comment we are all a little in dark.few people saying the Invesco selling was an automatic kick in initiated by risk mitigation within the organisation which is distinct from the investment arm and causing the huge drop.
Sure SG position will become clearer in coming days and yes could explain some of SP action before decision but M&G only bought in recently and Invesco have been fully supportive fir years and of course are hedged against selllong out lowvinnthat they have plenty of warrants

Hi Sheltie,
Hope you are OK mate.I am fine.
ATB

For eg if say none of the patients with elevated AST and ALT only received 40mg and MTFB but half had received 80mg and has mild liver impairment and MTFB were going for a clean label for mild impairment atbtyec80mg level I can understand why they might have asked for additional data.
If this was the case but doubt it was so simple then they could just adjust their label ton40 mg in mild/ moderate liver impairment if that was acceptable to both parties but need the meeting to clarify.

TP23 that is the kind of detailed info only MTFB and FDA have and may be basis of additional data request.
We simply don’t know.

Yep BARDA would be a possibikity

CFP- I wish that were the case but like to think the FDA would have just requested the data if available.
I could be wrong but suspect it is a bit more complex than that but love to be wrong.

CFP- there is no way imo they will be required to do a whole new p3 trial involving 600 patients to prove whether Iclaprim has any liver issues.They will use bio markers if available or simply amend the label indication” black box” like SJ has said with Delafloxacin.
That is the purpose of the FDA meeting to specifically find out what the FDA required to get Iclaprim Approved.That is why MTFB will not disclose the CRL detail or make any criticism of FDA or even play hardball unless they don’t have any choice in the matter.
Bit like you needing to obtain permission from a neighbour to get an extension built( obviously a lot more serious).Far better to discuss it in a rational and calm way rather than go in all guns blazing unless you are sure of your ground.

The MMs opened it up at I think about 44% down but such a huge number of institutional shares( possibly as an automatic reaction called by the risk advisers within Invesco) were put on the ask the MMscquicklybtook it down to 5p.
Many traders saw the opportunity and hence the big rise afterwards
You may have specific biomarkers to decide in advance which of the candidates are more likely to be part of this subset.This is not my area but for eg in renal impairment you can use SDMA as a biomarker for renal issues at 25% damage rather than the normal UC ration which kicks in at 75%.
I dont know what if any biomarkers are available for predicting which patients are most likely to develop liver issues.

CFP still need to know what the issue is with additional data.My main point was to establish if MTFB were being circumspect in comparing the liver issues but seem fine.Expkains why they would be shocked by CRL decision.
With all these things it is about establishing the data as being clinically significant so hence you need numbers and this is difficult with subsets.
When you get these low numbers it is very difficult to prove anything conclusively.Also these numbers can be compromised by further analysis like did they already have mild/ moderate liver impairment etc.
Agree GL needs to say something about current situation and even if he can’t go into detail about CRL they need to update the market with something.
They will have had w/end to formulate something and of course they and Walbrook will l have received a lot of requests to comment so hope some statement followed by a podcast etc happens soon.

Liver

Hi Sheltie,
My usual trips to London are either Company Meetings or MTFB related like AGM so yes happy to have a pint.
The liver issue ( raised ALT and AST leveks ) and Cardiac CTC issues were both highlighted last time but mainly due to weight related dose of Iclaprim.
Hence FDA suggested fixed dose to overcome these issues.It was not a small trial 600;patients in each group but the number of raised ALT and AST issues was small only 2% of population.in advance you don’t know which ones will be affected but could be some prognosticators, I don’t know enough about specific lover biomarkers

Alanine aminotransferase=ALT