Member Info for Ivyspivey

Very good day here and elsewhere so just shows eventually you get the reward if patient.

Hi Coggy I saw the transcript but did not realise the video was posted.Is about 17 minutes long and 17k views.
Fair dos if it is nothing new

Lots of mentions on FRR especially in later bits but can anyone translate

So get acquainted. This is Frontera Resources. The company from the USA, which initiated a competition for the largest Ukrainian Black Sea deposit "Dolphin". At first glance, this is a respectable firm with experience of international cooperation. But it may change somewhat. Why?

This is translated from a tweet about FRR a few days ago about the Ukrainian Dolphin Situation.Tgere is also a video but in Ukrainian

https://youtu.be/mPEsYPOEyy4

https://www.investegate.co.uk/motif-bio-plc--mtfb-/rns/holding-s--in-company/201906121752280288C/

Think it is a new one

No FRR representation but Hunt Oil Company.

https://www.amcham.md/userfiles/file/2019/US%20Business%20Mission%20to%20MD.pdf

Hasiba,
Absolutely.The point about bases covered especially in the case of Option 3 which it has turned out to be means imo they have a plan of action in principle.
So for instance the most expensive option ie a new trial and we don’t know the extent and cost of that would be along the lines of.
Have the meeting with FDA and establish whether a HABP trial with Linezolid is acceptable as a vehicle for delivering the data they require to satisfy their concern over liver toxicity.I can’t see the FDA having any issue with this.
Raise the required money to fund the trial probably by way of a Commercial Partner deal.They will already have been speaking to such a partner as they would have been very advanced discussion with them to do a deal like a JV for US Commercialisation assuming Approval was given.
So rather than fund say the HABP trial which would have been the Plan anyway and then putting the two business s together in a new JV they will seek to get the potential partner to fund the HABP trial but putting a less favourable arrangement for MTFB.
Or they are speaking to the ROW potential partners and get an upfront payment to pay for HABP but again due to lack of getting Approval they will do it on less favourable or conditional terms.
Obviously they will need to persuade any partners to fund the HABP but they will have discussed this fully by now.

The earliest you will hear anything is post FDA Meeting but anyone who expects deals to be announced before then is likely to be disappointed.

Looked some good cars in Cardiff lol

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

Pp I have known him very well for a long time and know they were totally surprised by CRL and yes it may be the FDA have changed the goalposts somewhat.
I am not so sure he was totally surprised at the conclusion of the minutes and knowing how cautious a guy he is he would have picked up on the degree of concern expressed by the meeting on 3rd May.Also a couple of comments like the one relating to discussing labelling on May 3rd and just the odd subtle sign that I have observed from his behaviour.
There is definitely no hidden agenda here to deceive SH and despite what some may think this is no lifestyle Company like some others on AIM.

My main contention is I don’t think it should be left up to SH to try and speculate about exactly what MTFB consider the liver toxicity concerns to be.I don’t mean publish the CRL just answer our questions in a more detailed and informative manner rather than just showing too much deference to the FDA.

Because I accepted the CRL was a total shock to them as it was to most LTH I accepted that but expected a better response.
I felt the podcasts were a step in the right direction and even at the AGM there was a return of confidence.
The performance during the Conf Call was poor and a few things mentioned there did not totally tally with my previous understanding and it us thus I am not happy about.
Fir the record I know that Invesco hold him in high esteem and I think it would be the worst possible thing for there to be any BOD changes as we want stability at the moment.
A bigger role for the new folk would be better and you would need time to get the right replacement and MTFB are hardly in the best position to attract the best talent at the moment.

Scott
Appealing to that generous and forgiving side.
We know you don’t like GL and you think he is a very poor excuse as a CEO.
I am sure there are many of us including me who are are very unhappy about the way the BOD have conducted themselves over the last few weeks.
However endless repetitive posts going over the same ground over and over again serve little purpose in either giving comfort to many who have lost money here or have any impact whatsoever on what will happen here.
Anyway if you sold at 8p or have an 8p average just be glad unless of course you want to drive the SP even lower as seems to be evidenced by your prolific activity today but again just be straight about your agenda.

SPThey also knew about the QTc and efficacy issues which were all rejected in 2009 and with the changes they seem to have satisfied FDA re these.It was the FDA that decided the trial protocol so either some of the data they were not happy with or they have changed the goalposts( 1st mention of latency in 3rd May Meeting).I don’t know what has happened.As for the BOD buying more shares we have been through this many times.It is just not standard US pharma practice.Rather than buy shares which can be taken either way I wish they would reduce their salaries to eke out the cash.Assuming Revive protocols have not been compromised.If a large trial is required think it would be harder to raise money and probably add relatively little as compared to a HABP trial.FDA have already said 1 ABSSSI and 1 HABP or 2 ABSSSI would be enough for Approval.A different comparator would strengthen Iclaprim case assuming it showed reasonable data.A HABP trial is more likely to attract partner funding as a successful trial would likely get Approvsl for both ABSSSI and HABP.Don’t forget fast track status and QIDP status for both.Twenty first century Cures Act could well mean only one p3 HABP May be necessary.I spoke to GL and JG at AGM about HABP.It is as called a great question by GL at Telecon.HABP is vital for any future partner.The Inspire trial protocol is all sorted.We are told all bases are covered.So what pathway do you think they might be thinking of.I am not trying to underscore the risk here and FDA meeting and funding are key but if institutions and Hercules stay firm,FDA meeting goes well and funding is sorted.I think the big question is funding any trial and I just don’t think the SP will be high enough to raise enough so my money is on some kind of partnership

Hasiba
I was at Merck at the time of Crixavan so well aware of HIV issues with FDA.
Back in 2009 the main issue with FDA specifically not approving ABs was due to their experience with Ketek now Approved which had issues with liver toxicity.

https://www.nejm.org/doi/full/10.1056/NEJMp078032

So the whole environment for ABs has changed re the issue of resistance.

With FDA collaboration MTFB moved to a fixed dose 80mg I/v rather than a weight based regime
It changed the comparator from Linezolid to Vancomycin and the NI margin from 12.5 to 10%.
It increased the trial sites to include more US sites and chose Covance recognised as leading CRO.
It appears to have worked with the exception of fully answering the liver toxicity concerns.

As you say many drugs like Ketec are Approved but can be associated with other side effects.
As AMR is such an issue you would think the risk / benefit of Iclaprim would be favourable and the FDA is not fully satisfied re the risk of DILI.

I still think Iclaprim will be Approved but equally aware it will not be a quick or cheap journey.Still risks ahead and need FDA meeting and then funding but big reward if they can complete this pathway

From 2015 link

I am particularly delighted to announce that today the Atlantic Council is launching a new partnership with Frontera Resources, a Houston-based energy firm operating in emerging markets. This partnership will help us expand our work on Ukraine throughout Europe’s East, particularly to include Georgia and Moldova. Steve Nicandros, Frontera’s chairman and CEO, is with us here today. Thank you, Steve, so very much for your support.

Old link from 2015 before I was a SH here

https://www.atlanticcouncil.org/news/transcripts/ukraine-s-economic-reform-insights-from-the-newly-minted-minister-of-finance-3

I knew they worked closely with AC but did nit realise they worked as part of a formal partnership

Hasiba,
Agree with most of what you say but for balance the EMA did not accept the Arpida argument on Iclaprim in addition to the efficacy concerns on a couple of safety issues namely QTc prolongation and elevated liver enzyme levels.
MTFB made a lot of changes with FDA Approval to improve the outlook and the whole AB environment has been transformed since 2009..

The FDA highlighted no efficacy or safety related to QTc ( cardiac) or CMC concerns in the CRL but obviously we still have the remaining issue of liver toxicity.

Happy to run through changes to phase 3 protocol for any new investors.

Something to look out for.

This was original link on p636 the FRR

http://www.gov.ky/portal/pls/portal/docs/1/12798481.PDF

However the next issue on Monday 27th May revealed nothing more about FRR but the next one is published on Tuesday June 11th and be interesting to see if their is an entry regarding the Declaration of Solvency which I understand should be published in the Gazette.

Morning Coggy
Good to see you in fine form and that your old sparring partner Dougal is back from the wilderness.
You must be overjoyed lol

As the story unfolds and none of us has been able to predict the future I have been struck by certain posters like Oopsi who are better able to plot the course of events so far.
The Fiduciary case so far has not provided any compelling evidence against Hope and we do know the legal process is process driven so certain key things to look out fir imo.

Declaration of solvency has been submitted which so far Maples seem to have accepted.I am sure it will cover all ORR debt triggered by the default and not just the interest payment.

The JVL now have the option of applying to the court for liquidation supervision if they believe FRR are insolvent/ unlikely to pay within 12 months or if they feel the court is required to expedite the process more quickly.

Next bit to look for is any evidence of JVL asking court to continue liquidation proceedings.This should be clear from cause lists in next week or so.

I am sure declaration of solvency despite potential penalties will involve more than just a statement saying SN/ZM can meet the full commitment.It will require proof of payment ability.

So if no JVL application to court that is great news.If they do then I presume this “ proof of solvency” will be examined by the court unless it is a formal part of solvency declaration document and lawyers from both sides will argue the case.
Obviously if FRR can guarantee the full settlement and satisfy the judge then there should be a stay on liquidation proceedings for the 12 month time.
But given the ups and downs here I would not be surprised at any eventual outcome here