Member Info for Ivyspivey

We may disagree over the issue of whether foregoing salary for a few months will make any difference either symbolically or materially but to suggest it will make any difference to getting this over the line is total fantasy.
If you really feel this is about snouts in the trough then you are simply wrong in this matter.If like me and rebarm you attended the AGMs and investor meetings you may be able to get a better feel for the motives of the individuals themselves rather than just venting and looking for someone to blame.
I can assure you the “ snouts in the trough AIM BODs “ will also be vociferous in shouting out the chances of success to all and sundry and it will be mainly a retail audience or death spiral financiers involved.They certainly would not list on Nasdaq and be US citizens with all the attendant SEC consequences if they were simply milking the system.
The last thing we want to do is fall out over a sideshow when the main events are what will decide the outcome here.ATB everyone

Yes that is a big reason I invested here and I have been critical where I think it has been neede like on Nasdaq lodging and not having a contingency plan in case of the CRL.
If it makes people happy for GL and JG to forgoe a couple of months salary and save £120k then fine but personally would just rather the don’t take any bonus which they wont on non Approval.
Yes they have lots of options which yes has not cost them any money but is part of package in terms of forgoing a much higher salary but no matter. Currently the CRL decision has probably cost GL in order of a few million but again no matter.
I just want the key people completely motivated in the current situation to sort it out and Inhet SH are looking to blame someone but at this stage we simply don’t know who is at fault if anyone.
Anyway realise I will be in a minority but as always I am much more focused on the FDA meeting and any cash raised than saving 2 months salary

Why would you give away commercially sensitive info and possibly cause friction with FDA when you don’t need to.
It is the institutional investors here who are critical to the future here in the short term so let us just kebthem he one with trying to get it of current situation

Kelsbells,
Think they have the partnerships in place but all depended on Approval to secure best deal hence was a big shock to BOD.
Without knowledge of exactly what liabilities may be due it is hard to predict exactly how long the cash will last.Maybe they have to pay another PDUFA fee to FDA to resubmit( they had a waiver last time) I simply don’t know.
The cash burn of Salary and routine admin is relatively low hence why I am not unduly calling for salary sacrifice.etc.I am surprised by lack of contingency plan and not sorting funding out prior to CRL simply to keep options.
Also the timeline of FDA meeting is outside their control so for eg what happens if Trump causes another Govt
shutdown.
That is why I am reasonably confident they will raise before meeting

NaP
Like yourself I main broadly positive here about the outcome whilst not trying to dismiss the risk that has arisen due to the CRL and the need to raise funds.
What I do know is this is not a lifestyle Company simply spinning out the timeline to continue to benefitfrim their current employment.We don’t know the exact FDA concerns but let us look at what we do know or can reasonably assume.
1.It appears that apart from the dramatic dumping by Invesco and M&G on the day of the CRL which forced the price down to 5p and again the evidence is that it was purely as a result of their risk mitigation rules rather than their investment side.The institutions appear not to offloaded any more.A big positive.
2. The CRL highlighted additional data on liver toxicity.We don’t know what this entails but look at what it did not mention.No mention on efficacy,no mention on any cardiac safety or on any CMC issues.So again big positives over what happened with the Arpida submission in 2009.
3.FDA will approve if drug benefits outweigh risk.I am pretty sure this will be case for Iclaprim but may involve a labelling change,warning or more post marketing surveillance all of which you can still get Approval.
4.We know there were several interested parties I doing a commercial deal.
So the choice is have FDA Meeting and raise or raise and have FDA meeting.You can put the main expenditures on hold and I don’t think they will want to take this to the wire by having FDA meeting first unless they simply can’t get the raise.
So to me they will attempt to raise first and support of existing institutions is critical so they must have soothed their concerns in short term.MTFB will know the likelihood of what is needed to satisfy the FDA requirement and the actual meeting will just be to confirm the pathway forward imo.
I believe they will announce the financing before an FDA meeting and that is a huge clue as no one will support unless they believe there is an extremely good chance of success with FDA and MTFB will have to give more detail on the precise nature of the concerns raised in the CRL to these institutions and they will have internal experts to assess this detail.
So radio silence from BOD and then newswhen it Is finalised

My guess would be that you will get radio silence until news is released.
Agree there are elements of complete lack of leadership in moving forward re communication by BOD but again much more focused on what is happening behind the scenes than what is announced publicly.
As for public measures to apply laser like ficus like salary sacrifice.
Yes this would help show SH empathy here but really feel these are token gestures and again much more concerned about big ticket expenditure and what they are doing to get the situation sorted.
They only have 8 employees so salary cash burn is still relatively low and yes they need money but the msinndeterminants of moving forward are the FDA meeting and fund raise not receiving half salary for a month or two

Yes post marketing surveillance coukd easiky help provide any additional data.
None if us know for sure what the specific issues are but likely clues in near future.
For eg if they manage to raise necessary funds and this can be for all kinds of things nit just support any additional data stuff that us a huge clue to being minor issues.
If they can’t raise then that us a big clue in opposite direction lol
They may have meeting first before raise but again that is a good sign as they know if a major issue then they will have to come up with an alternative plan.
They will know extent of issue due to contents of CRL the meeting is just to finalise steps to Approval imo

Morning
Clear in my mind that the benefits of Iclaprim outweigh any risks and if necessary you can simply make any labelling changes.
Coming more around to idea yes the FDA do have need additional data to address some of their liver toxicity issues but these are not a major issue and we will get Approval.
If you think how desperate they need new ABs so a novel one with low propensity for resistance to use in renally impaired patients rather than Vancomycin must be a useful addition to the AB armoury

See they are FRR website designer and digital IR agency

https://www.brighterir.com/

http://cbw.ge/banking/u-s-embassy-tbc-case-result-can-have-significant-implications-for-georgias-reputation/

Antha,
No formal medical training but have worked in pharma for over 30 years in sales and marketing with Merck,Sanofi,Eli Lilly and with my present Company so have a lot of a wide range of drugs including ABs.

Morning Dave,
Good result last night.
CFP you may well be correct about the subset info as these numbers are so small they are unlikely to be statistically significant so depends a lot on whether MTFB wanted a clean a label as possible and that what additional data is required.
We simply don’t know and also what biomarkers are available if any to predict which patients are likely to developedvrsused AST and ALT levels.
Crucial thing to me is no permanent liver damage and enzyme levels returned to normal as the liver is the most regenerative and responsive major organ of the body.
It may be that a simple labelling change can allow Approval in the future without a lot of additional trial work if any.
We simply have to wait for more news.It may be it was about what dose rate to use in mild or moderate liver cases but news of a good cash raise/ who supports/what terms will be a big clue as to what the chances of success here

https://www.sciencedirect.com/science/article/pii/S2213716518302078

Hi Jam,
As you say should not take what Wiki says as gospel but couple of comments.
Firstly the recent Revive trials demonstrated Non Inferiority(NI) to the comparator standard of care drug ie Vancomycin and QTc is to do with cardiac issues rather than liver issues.These were not raised as a concern by FDA recently.
This improvement is as a direct result if the changes to the dosing protocol of fixed dose Iclaprim
There are unresolved liver issues which was raised last time as well but there has been a dramatic improvement since the original Assust trials back in 2009 as well as a transformation in overall need forcABs

Morning.
Yes still risk here and need news on funding and FDA concerns meeting.But huge number of people watching this one and once we get news it will respond accordingly and should be some clues along the way

Is Y-T-D figure.

The Add Comm question is one for the FDA

Vascular the target market forcIclsprim is renally impaired market so a limited hepatic claim would imo not be a major issue.
These patients are in a hospital setting and get regular ALT and AST levels checje3 so no real additional cost

Hannibal.No it would be pretty straightforward.Either provide additional data to support claim and get FDA Apprival or amend label and resubmit

Hi Vascular,
Part of problem is people claiming they have heard it is a labelling issue orvtgey have heard the FDA raised questions in January.
I am of 2 minds on the one hand I find it hard to believe Walbrook would give out any info to any investors at this particular time.However if they have then I have no reason to doubt it is true.
Taking people at face value,if the FDA did first raise the liver toxicity issues in January and MTFB have been in total lockdown since December then it could well be a labelling issue as these are normally handled at a late stage.
The FDA are hardly likely to raise a fundamental issue a few weeks before PDUFA date imo