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Hopefully now AMP has sold off another chuck of holding which is reason for today's drop (including late report trade of 1.8m sell? from friday just showing now). Would expect to see a reasonable recovery now.
Just my two pennies worth - the drop in February and further post dilution drop took us to about 6p - we are no different to that position now i.e. future potential albeit requiring further trial of some sort and asscoaited fund raise needed (not a full Phase 3 as GL confirmed in telecon!). With Hercules / Invesco still holding for now is also another major positive.
AMP were holding on with hope of good outcome. With latest setback looks they have offloaded another big chunk but in anycase AMP is a write off now and has been masisvely dragging down MTFB SP. Hopefully they just hold hold remaining for a while.
I am positive that MTFB can get this over the line as they have invested too much to throw in the towel and the reward is still massive. Obviously each set back destroys shareholder value and limits upside. Once we are clear on plans it will be interesting to see how funded, imo:
i) Further SP offering - unlikely - will dilute this to buggery and not raise much in any case so why bother.
ii) More debt - very possible as GL mentioned on telecon Hercules still onboard and they have potentially the most to lose if this MTFB goes under so a further investement to secure longer term return
iii) Commercial Partner - very possible as there is a clear demand for the product and there is significant investement required to commercialise a new drug product in any case so a partner funding now and taking a bigger slice of future profits pie is an option.
iv) Takeover - possible but not sure how the regulatory side would work switching ownership midway; better way is route iii) initially with full takeover following NDA.
So we've had more than our share of bad news updates and could do with some positive news just to steady the nerves. Sandgrove selling is dissappointing but the fact still remains there has been significant buying - even today 3.57m buy vs. 2.36m sells is at odds with SP drop.
Hopefully some more TR-1s should shed some light. This is also the time need GL and co. need to keep us informed
on these so called options and timelines (eg. follow up meeting with FDA).
Hi Ivy I know you have met GL F2F but on telecon it came across he was not expecting this outcome. As many have posted at the FDA meeting options are considered but final outcome will only be known when minutes received. So don't believe a hidden agenda to deceive investors - hence still invested for now.
Yes the BOD could be more savvy and have better managed risks (but that is all on hindsight) - I still believe he has II's support - but part of this is also down to unpredicatbility of regulators and what could be considered moving goal posts!
Would be interesting to hear your views as BOD now have a massive role pickup pieces and getting this over the line...
E_AL
Agree way oversold; key drop was 14 February.
The latest drop excerbated (imo) by AMP selling its remaining holdings and many PI's have also exitted. Next key sign of confidence is TR1 updates from II's - if they are still holding then still they have some conifidence MTFB can still find a way forward. If II's however start selling then may as well throw in the towel.
This is where GL + team have to earn they keep - if there is a way for a tactical study to address FDA's concerns over elevated AST levels without a complete P3 re-trial (as GL insinuated) then funding is conceivable beyond Sept via some further dilution + debt and/or partnering arrangement that still offers investors a good upside.
Jimmybob - that was my take awayfrom call, certainly MTFB not planning a full trial (cannot afford it) but need to get additional data to allay FDA concerns. Not sure how they do that as GL himself said as it was such a small figure (1.8%) of total hence the reason for no extended testing in Revive trials (either naivety and/or stupidity!!).
Agree privateryan - it was like getting blood from a stone. Does look like a step back although GL did say it’s not a full phase 3 but more a targeted trial to address FDA’s elevated ALT latency. With hindsight it’s easy to say do further tests but maybe not enough funding at time to extend test by a further 2-3 weeks. GL was also adamant this was a new concern raised by FDA hence why they were not prepared.
Not bailing yet as there is still (I believe) progress to be made and value to be had. Will see how things pan out next few weeks. It’s also interesting that they are looking at various funding option beyond another equity raise. More borrowing and/or bring in partners were cited.
Agree not a clear RNS. Whilst not best of outcomes there still appears a route to market - some funding required by MTFB + commercial partners may contribute. Last week's AGM decision on salaries could be pertinent to conserve cash in short term.
Hopefully this afternoon sheds some light on the further data needed and associated trial requirements. Whilst the negativity today is overdone we need some answers soon!
The RNS says new data - not sure if that means a) re-analysing data they have to address FDA concerns or b) creating brand new data (ie. from a further trial). The two outcomes are very different.
Hopefully, Ivy or someone that attended the AGM can clarify as the RNS is ambiguous!!
Another great update.
With the recent NED announcement and now this news plus the fact two experts are going to the FDA meeting on friday suggests MTFB are extremely confident of a positive outcome.
Today's news should give the FDA plenty of food for thought in that Iclaprim is a versatile drug substance for lung related infections giving even more impetus for a favorable decision (and hopefully quick NDA).
i'm sure that's the case as manufacturing antibiotics is quite stringent with few manufacturers with competancy eg. FDA/US markets would not accept many India / Chinese suppliers.
So would not be surpised if MTFB have a favoured commercial partner in the wings as it will take at least 2+ years to bring any finished product to market
Looks like Andrew Powell onboard to advise on taking MTFB forward with the commericalisation strategy:
This reinforces my view that MTFB believes it can adequately address the items flagged in the CRL and is planning the next steps. Hopefully the imminent meeting will be a rubber stamping exercise allaying any FDA concerns.
So all looking far more positive!
agree marineville - v good news,
FDA CRL is a hiccup more than total deal breaker.
All signs back that MTFB on track. I really hope there is a fastrack NDA approval route so MTFB don't have to wait another 3m+ for resubmission.
"Unfortunately, in February 2019 we unexpectedly received a Complete Response Letter from FDA notifying Motif that the NDA for iclaprim could not be approved as submitted. The Agency has asked for additional data to assess the potential for liver toxicity and we have a confirmed FDA meeting date of May 3, 2019 to discuss the concerns noted in the Complete Response Letter. We expect to be joined at the meeting by two external experts and anticipate a collaborative discussion and hopefully an acceptable path forward."
Reading between the lines IF at the meeting any concerns are adequately addressed (including with necessary Expert input) then looks like 3 months for minor amendment? Not 100% sure on timescale or if there is a fast track option (say if only labelling work around). I would hope the MTFB is currrently already working on updating its submission for this scenario so its ready to issue very soon after meeting.
Another factor - normally would use one expert (as they are not cheap) but the fact there are two attending the meeting, would suggest, imo, MTFB has a high confidence in addressing issues raised in CRL.
In lead up to FDA meeting circa 25p not unreasonable even factoring the recent dliution; the drop was way overdone.
Am sure post 3 May, MTFB will know if this has a possible early route to market and big II's will be lining up in background.
Agreed this was way oversold - with AMP adding to pressure; let's hope we get back to sensible SP soon.
I still believe there could be a short term fix (i.e. an approval with a watching brief to manage risk to patients) as AMR is one of the biggest medical challenges that needs to be addressed immediately, any new antibiotics are a necessity (even if there is some downside) - hence fast track FDA approval for iclaprim in the first place .
I have a very high average too so part wishful thinking but also pragmatic. We were ~40p pre CRL , admittedly that was a binary approval / no approval.
But now circumstances are not too disimiliar but probably three outcomes (1) NDA with caveats (labelling etc); (2) some further testing before NDA awarded; or (3) worst case extensive re-testing/trials where MTFB would require major dilution to fund or they throw in the towel.
People seem to forget that this has passed Stage 3 trials - this is a massive de-risking and very few NDAs get this far. So imo we are now jumping through final adminstrative hoops to get this over the line. If outcome (1) happy days and thats the basis of the 25p; outcome (2) will require a further placing to fund testing - the unknown is what is needed and the level of further dilution - but we still hopefully can be better off than present.
Let's hope we are all pleasantly surprised over the next few weeks!
So based on various RNS' today Invesco / Sand Grove still holding same (or similar amounts) - TR1 is just an update restating based on last weeks placing. Also AMP appear to be using additional holdings of other investments as security for loan - maybe (imo) trying to hold on to their MTFB shares until the FDA meeting as surely there is signficant upside in the short term rather than firesale disposal which doesnt help them or their lenders.
Hopefully this suggests SP consolidated at the current levels and optimistic that between now and the meeting on 3 May 2019 there should be a significant gain to SP; ~25p is not unrealistic (i.e 30p pre-CRL level less 15%) imho.
Just in last 30 mins someone has hoovered up 6m+ shares over 4 trades. Suggests this is now on II's radar given the short term derisking due to today's RNS. Would be reassuring to see this climb back over 10p for starters
Invested in this a while, but dont post here, like other LTH dissappointed at events leading to current position. But looking forwards the phased placing is a good approach, MTFB must be confident it can address CRL (timescale a different issue). When we get past that point SP will increase (hopefully 15-20p) and require a further placing based on route to placing (2m - 18m??). This limits PI dilution which is a good thing and only funding what is required. Also if the only labelling issue to get this to market there is also prospect of a commercial licensing agreement being struck.
Even taking a setback of say 6 months to FDA granting NDA the SP should be closer to pre CRL levels so believe there is now massive upside.