Member Info for Ivyspivey

Morning.
Whatever the outcome here we can at least hold our heads up high in terms of being decent folk who actually care about the important things in life like health and happiness.
Of course we all want to do well financially but not at the expense of putting it at the epicentre of our world and not caring a jot about the very serious human implications that being invested here can bring about.
So unlike many of the sad folk on the other sites who highlight and glory in the suffering or potential suffering if others.
ATB

DM.
Wishing you a speedy recovery mate

Robert J. McCormack, Ph.D., Consultant, Regulatory
Dr. McCormack is a Regulatory professional with more than 25 years’ experience in the pharmaceutical sector. Currently a Consultant in Regulatory Affairs and Quality Assurance, Dr. McCormack provides strategic planning for clinical development, FDA meetings, IND, and NDA/BLA filings, planning, preparation and/or review of regulatory submissions including INDs, Type 2 DMFs, CMC Technical Data Sections for INDs, ANDA’s and NDA’s, preparation of FDA meeting dossiers, represents clients at FDA meetings, and performs due diligence activities related to the in licensing of various compounds for development. Dr. McCormack was previously Vice President, Regulatory Affairs and Quality and Vice President, Development, at Cubist Pharmaceuticals, a successful antibiotic company recently acquired by Merck & Co., Inc. for over $9B.

The FDA can send a response anytime between 30-45 days from the Type A Meeting.
Apparently during the meeting on 3rd May the FDA restated this but Bob McCormack responded by saying it was important to have it within 30 days.
It could come literally anytime but please do not get hung up if it is later it does not mean anything about the likely decision.
It is not as date specific as say a PDUFA date.
I do expect it 30 days from 3rd May but let us just wait and see

Thanks Reg.
RR-was aware of YJ comments was just interested in any views from posters that may have personal insight as to what is happening or involvement of BP/BH on the ground.
Dulwichman- you can add the current opposition to Nord Stream 2 which has reared its head again and we can all see behind the scenes that FRR can access the funds to pay Hope off-assuming of course the assets are there and they can monetise them.
If this has all been about delaying things and regaining control from Hope then looks a good outcome but as FRR have been peddling this line for a few years now it looks like the moment for truth is fast appriaching

“Do not have access”

Morning RegD.
Very good post and know you have good contacts with some of the players here and I for one think you are one of the very credible and trusted posters on here.
Sure you can understand that many who do have have access to “ what is happening on the ground” and in the FRR vacuum will mostly presume that tangible progress may not be as smooth as you suggest.
Is there anything you can share to help those folk who think nothing is happening on the ground to reconsider their opinion.
TIA

Even looking at if the solvency declaration is not submitted then JVL ie FTI Consulting needs to apply to Court which lengthens the process( not sure how long) for permission to continue the process.
However does any failure to submit the declaration simply delay the inevitable or can they then again “ appeal” at a later stage ir having moved the “ assets” can FTI complete the seizure of Block 12.
It is good to have info in real time but without expert legal input like Oopsi given the twists and turns we have had here who would bet when this will end.
However the 28th Deadline re solvency declaration will be a critical point good or bad

The directors’ declaration is a declaration or affidavit in a prescribed form which confirms that a full enquiry into the company’s affairs has been made and that, to the best of the directors’ knowledge and belief, the company will be able to pay its debts in full, together with interest at the prescribed rate, within a period not exceeding 12 months from the commencement of the winding up. The declaration must be signed by all the company’s current directors. Any person who knowingly makes a declaration of solvency without having reasonable grounds for the opinion that the company will be able to pay its debts in full, within the period specified, commits an offence and is liable, if convicted, to a substantial fine and/or to imprisonment.
If a directors’ declaration of solvency is not filed within 28 days of the commencement of the voluntary liquidation, the liquidator must apply to the Grand Court of the Cayman Islands (the Court) to have the liquidation continue under the supervision of the Court.

Liquidation Procedure Declaration of Solvency

https://www.harneys.com/media/1393/voluntary-liquidation-of-a-cayman-islands-exempted-company.pdf

https://www.fticonsulting.com/our-people/david-griffin

Hope that FRR can complete solvency declaration as must admit don’t like the tone and implication of some of their allegations like FTI not independent and in league with Hope.
If they have evidence fine but FTI seem to be a global outfit with a reasonable reputation and not sure Judge will consider them anything else in being impartial

Nothing inconsistent with appointment of Powell

http://www.lse.co.uk/share-regulatory-news.asp?shareprice=MTFB&ArticleCode=gzciv3cl&ArticleHeadline=Appointment_of_Andrew_Powell_to_Board_of_Directors

and the continuation of US Commercialisation strategy pre CRL.

He has lots of experience in partnering and JVs etc which is clearly MTFBs strategy and has been for last 2 years.

Also talked to JG the interim FD so often highlighted.Once the pathway forward is clearly established based on the minutes it is likely that the FD moving forward will be either a new hire( with a different skill set) or one already employed by any potential partner who already possess’s the relevant skill set for the change in ficus

Absolutely correct about how to value a pharma.Two normal ways are DCF cash flow or peer valuation.
This close to market DCF is the obvious way to go.
But let us get minutes and sort out which pathway and cost then how to fund pathway and then go from there.
Have to take into account partnership arrangement with US partner and potential for synergy then ROW deals then HABP etc.

Lawson.
I know it seems very hard to believe given current situation but Doc P is right about cost of getting a drug Apprived

Agreed a decent interview and entirely consistent with what was said on Wednesday.
To clarify “ additional data” is exactly the wording in the Feb RNS so it is not new ie is a different requirement as a result of May 3rd Meeting.
Minutes mean they state their case the FDA reconvene independently and decide based on discussions and submissions of meeting and decide on the pathway forward the decision.They then issue minutes with decision so that until official receipt MTFB will not know how to move forward.
So minutes are not simply a recording of what a said and that both parties would be able to predict the likely outcome.

The words” potential “ liver toxicity was raised.That indicates to me that it is about potential long term risk of DILI based on prognostic indicators of raised enzyme levels.
This appears to be the major point of argument between the 2 parties.
So looks like no particular liver toxicity concerns over patients treated in phase 3 studies based on current status so to me unless it is a specific concern about a sub population then what is real point of repeating a whole new phase 3 trial.
If the concern is about the long term then makes more sense to follow up those who have already taken part in Revive trials and to maintain status quo approve with either labelling changes or post marketing studies.

Of course this is pure thought on my part and yes we all need to await on the minutes for confirmation but to me this is what the board us all about.Talk through the options god and bad and have a balanced debate

Thanks Taffy.It does not look good but IF SN/ZM complete declaration of solvency which at the end of the day is the crucial matter to repay the debt in full then that would probably bring things to a head and hopefully just pay Hope off.
If they won’t do this then it the whole project looks less like it is more like an episode of fantasy iskand

Hi Rebarm,
Very illuminating reading some of the posts and how different people interpret the same words in totally different ways.
Take the word “ minutes” I did not know exactly what they meant in the FDA context so I asked and have reported back the answer.
However there are a plethora of folk who think they know what that and other phrases like “ additional data” exactly mean.
We all make decisions on how we see things and that is fine but personally prefer to try and acquire as good as insight as possible rather than a gut reaction.
Today when I saw the rise I thought I should sell some knowing it would likely fall back as nothing new was likely going to come out of the meeting but had no opportunity as travelling but good luck to those that did.

These would still possibly require the submission of a new NDA

I did not know exactly what they reflect which is why 2 questions were public ally asked specifically at the AGM.
They were asked again in the private conversations afterwards and I can only report back in the answers given.
My guess is they obviously do know more about the specific issues than what they are reporting but to suggest they may have a strong idea good or bad on the outcome was not forthcoming.
One interesting thing which came out strongly was the fact they considered there were 3 possible likelihood’s rather than the 4 options mentioned recently by Vadim Alexandre.
The 3 are.
1.Approval with no further data which may or may not include labelling changes.
2.Approval but with conditions and subject to additional data in the form of Phase 4 post marketing surveillance.
3.Additional trials.Again interesting that this could take form of a HABP/VABP trial just looking at including the Liver data as part of an NDA discussion.
The other outcome of an outright rejection they seemed very dismissive of so readibtonthat what you nay

Investment Wizard
The minutes are not a formality.That is the whole point.I and others asked specifically about what the minutes reflect.
Is it merely a confirmation of what was said like many interpret or a much more important response similar to a jury being sent out to reach a verdict.
It is much more akin to the latter so until they receive them they do not know exactly what the FDA requires.
If Jay is looking in he can give his thoughts as he was there