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Thanks Ivy. That's a serious conference! MTFB's posters are a great opportunity for promoting Iclaprim and also progressing any work they are doing regarding EMA submission following, hopefully, approval from the FDA.
PR, no I don't ignore all the factors but, as I'm sure you will agree, there are just too many imponderables and debate about options over which we have no control is a waste of time. Until such time as mtfb have the meeting minutes in black & white from the FDA imo they are unlikely to release any information in advance. As for share price, do you really think the FDA care? Their interest is quite simply to ensure that they only approve safe and efficacious drugs.....such as Iclaprim!
MTFB have, quite rightly, followed FDA guidelines throughout. By doing so it reduces FDA rejection options. With regards to meeting minutes, imo nothing will be released in advance of the FDA's formal minutes. The reason why is that the interpretation of what was said/agreed in any meeting can vary according to which side of the table you are sitting. By releasing any news (MTFB's interpretation), even a hint, in advance of the FDA's release is a risk that I do not believe the BoD would be stupid enough to take.
LTHs have been patient for a very long time. What's another couple of months?!!
Ivy/Ian as always excellent scientific analysis to which I’d like to contribute a commercial bias.
As far as I’m aware mtfb have never submitted as many papers/posters to one conference. Why would they do this when they appear to be under the cosh?
IMO two strong reasons: First is a very strong message to FDA and market.....’F*** you we’re going to get sign off for Iclaprim sooner rather than later’ A very strong statement of intent from our BoD which is a strong rebuttal of all the recent negativity directed at them recently. Second very much laying the groundwork for EU approval following FDA sign-off.
I’ve wobbled like most LTHs but never lost the faith!
Vas, the 80mg fixed dose was recommended by the FDA
Jimzi, normally agree with your posts but on this one have to beg to differ.
Yes, they need cash but we knew that pre 14th Feb. It’s a prerequisite for the P3 HABP Inspire trial. What the CRL has triggered that prompted GL referencing it on the recent webcast we don’t know. Why, what and when has not been answered so at this stage it is all negative speculation. He could just have been setting expectations so that IF there was short term cash call the market wouldn’t be overly reactive. We just don’t know.
As for making a sacrifice, moderate or otherwise, proving what sort of person you are, quite frankly, doesn’t help sort this mess. I’ve met GL on a number of occasions, as I’m sure you have, and he’s a decent sort and having listened to the webcast again he is clearly shocked. I don’t need him to prove what sort of person he is, I just want him to prove that he is worthy of the CEO role by getting the FDA approval and Iclaprim making commercial progress. To be honest Jimnzi I’m sure that’s all you want!
DrS, taking a salary cut does not imo show any confidence that they will get Iclaprim over the line. There is no connection whatsoever and as such it is irrelevant. All taking a salary cut would do is make a bunch of PIs feel good about themselves. Don’t lose sight that we have no influence on what’s going on at and with mtfb and if you’re worried about snouts in troughs perhaps you should have done better due diligence into the BoD before investing.
Of course, I could be completely wrong and it may turn out that we’ve all been conned and lose whatever we invested in it’s entirety!
Anybody buying into a single development biotech company is taking a mega risk but hopefully one that individuals can afford. Whilst mtfb was nearly over the line there was still a risk that something/somebody would foul up and it duly did.
Sorry fellow PIs, we took a risk and are now sitting on large % losses. No point in moaning it was part of the risk and nobody gives a ‘..........’ (fill in the blank as you see fit) if we are sitting on a paper loss. That includes the BoD, the FDA, the IIs etc etc Furthermore, given the substantial stake that IIs still hold in mtfb, PIs are even less of a consideration. We’re no more than a nuisance..........fact!
Picking up on the BoD’s salaries which many think should be given up. Why? To keep the chat on this board happy ? Because nobody else cares. If the IIs wanted token salary cuts it would have happened but hopefully they recognise the benefit of a BoD staying motivated through a very intense, stressful period. Yes, somebody’s dropped a big one but it’s history now. There’s no point in beating up these guys. It won’t help get Iclaprim approved or the sp back to a sensible level.
I want ABBBSI patients to benefit from what appears to be a revolutionary treatment but apart from that I have no altruistic reasons for investing in mtfb. So much so I would be tempted to award the BoD a truckload more options if they manage this over the line!!!
A number of posts recently from burnt investors slamming the BoD for not boosting shareholder confidence by buying MTFB shares. Why should they?
There have been many very clear posts on this board covering the remuneration of MTFB management and reasons for them not buying shares in the company but to reiterate. Whilst MTFB is a UK company it has a Nasdaq listing and focus on the US market and, as such, senior management are remunerated in a fashion similar to their US peers – low salaries (relatively speaking!) and heavily incentivised through share options.
In March last year the key executives, GL, JG and DH, were awarded a significant number of options under the companies share option plan. In the case of GL, they vest over a 4 year period with two thirds based on meeting performance criteria. I don’t know what they are but typically one criteria would be sp performance. In other words, he can’t get the full benefit of those until 2022 and that is pre-supposing the performance criteria are met. I do not have any information about earlier option awards but would expect that any previous awards would also have performance criteria attached. Those 2018 options have an exercise price of 36.1p!!!
Whilst we, as shareholders, experienced a heavy loss last week there is still some value to our holdings. Based on last week’s closing price and last year’s option award, the executive team have absolutely nothing! They clearly have a big incentive to get this approval hiccup sorted and I still have confidence in them achieving that although it will take longer than I had originally expected.
Very well thanks Ivy. Hope you've come to terms with working until you're 90!!
I've never been a prolific poster and been particularly quiet over recent weeks as the quantity of posts has increased and the quality decreased. Thursday and Friday's mindless irrelevance from individuals, many of whom probably think Iclaprim is a new energy drink, was more distracting than the sp movement. No doubt the traders will be on duty early tomorrow morning. This weekend though has been valuable with some good balance in posts and I feel many LTHs, including myself, are more relaxed about the situation than we probably were on Thursday.
I'm sure GL will be in London next month once MTFB have met with the FDA and clarified what data is required to address their concerns. If so I hope there is an investor's evening of some description and an informative Q&A session
Last Thursday was the 90th anniversary of the original massacre. Unlike the unlucky 7, as MTFB shareholders we may still be in a state of shock following the FDA’s CRL and certainly a lot poorer but we’re still alive and, hopefully, ready to face another tumultuous week.
I’ve spent the last couple of days digging through and digesting the mass of earlier data as well as considering the measured posts from knowledgeable regulars such as Ivy, Sheltie, IanB. Also bearing in mind, nobody, including the BoD, knows why the FDA have taken their position, my speculative conclusion is that this is no more than a setback and is not terminal. LTHs have had to show extreme patience over the years so another 6 – 12 months shouldn’t be overly inconvenient though I appreciate some plans such as exotic holidays, new cars, early retirement etc. may have to be put on hold temporarily!!
Reasons for taking this position? The FDA mentored MTFB in the P3 trial design which was structured to meet their success criteria. They are effectively ‘partners in crime’ if it transpires there is a serious flaw in the trial results. Given their function, integrity and accuracy are paramount and, if some significant oversight on their part becomes apparent, their credibility would be questioned very publicly. Therefore, imo there is nothing major to be concerned about regarding MTFB’s NDA submission and the CRL request for further information.
What has been flushed out in many posts over recent days is the frequency of CRLs and what should have also been noted is that the highest percentage of those CRLs are received by small companies such as MTFB. Is that because they lack the political clout of the big pharmas and can’t push back? Also referenced in numerous posts is the US Govt shutdown and the impact on costs resulting in the FDA possibly using CRLs as a delaying tactic to save money. Consider last Friday’s news release about increases to the FDA’s 2019 budget. Their overall budget for 2019 has been increased by 9% but of most relevance to MTFB is an increase of nearly 50% in the budget for the Center for Drug Evaluation and Research (CDER) which, I understand, is the FDA department in which an NDA is reviewed. No government department ever gets a budget increase of 50%. This suggests to me that in previous years they have been seriously underfunded and, as a consequence, a sizeable backlog has built up. What better way of managing that backlog, until increased funding is available, than by delaying reviews from small inconsequential companies, particularly tiddlers from the UK such as MTFB, that have zero political sway in DC?
In short, I’m pee’d off with further delay but I am as confident as I can be under the circumstances that the reason for the CRL is relatively minor and the real reason is workflow management and that MTFB will come good. In the meantime, the current share price represents a brilliant opportunity to average down and increase a holding.
Great post Jimzi. Worth checking the background of SAD members. Extremely well connected and in influential positions. Undoubtedly they will be spreading the word and, given their positions, will be listened to.
Ian, they're clearly in agreement over the water given the sp jump on Nasdaq tonight!
It's important for me, as I'm sure is the case with all LTHs, to check any story, publicly or privately, that might rock the boat. Whilst I'm very confident of the success of Iclaprim, until such time as we get FDA approval and a commercial agreement in place then I can't be 100%. I'm sure you agree.
Link might help!!!
https://www.fiercebiotech.com/biotech/at-end-a-bumper-year-for-approvals-fda-hit-by-government-shutdown?
Ian, this was in today's FierceBiotech from FDA commissioner Scott Gottlieb.
References both drug and medical device reviews being impacted. One point worth noting, 'NDAs/BLAs/PMAs have their own product user fee. Companies that have filed and paid the fee can expect FDA to continue the review, even during a shutdown'. I don't know the relevance of this and if MTFB's NDA covered by this category. Any views appreciated
The FDA has been impacted by the US government shutdown - and a happy New Year to you too Mr President!
Around 50% of staff have been laid off but don't know what FDA departments or programmes have been affected. Worth keeping an eye on this as it may have an impact on MTFB's February FDA decision date.
Many thanks Sheltie. I'm sure it will help shift the heavy weight that's been holding the sp down for so long. It might also explain the unusual dominance of buys on Friday's!
Not long to wait now!
Merry Christmas to all MTFBers and best wishes for successful investments in 2019.......particularly around February!
.......to conclude!! If nothing happens I for one will start to get a little uneasy!!
Snaffleman, unfortunately I don't have an answer to your question other than I totally agree with your sentiments. The Nasdaq listing was a debacle and, as yet, no clue why it appeared to go so badly. A couple of observations:
- the current CFO, although interim, joined after the listing so is not to blame
- was it pressure from the US IIs - Sand Grove & BofA? Lots of speculation about the relationship, if any, between the pair but no real explanation.
- was it pressure from UK Its on the basis that if you're targeting the US market then you need a US listing?
- Nasdaq is flooded with US biotechs so difficult to raise profile - no excuse imo
- point that has been made on this board a number of times is that big pharma is not interested as Iclaprim is a short term, hopefully one-off treatment. Understandably they prefer investing in life-time drugs e.g. statins
- worth bearing in mind that a number of AIM listed biotechs have gone down the dual listing route and have seen no real benefit other than extra cost e.g. SUMM & MTPH
With regards to your once bitten position, despite the very attractive sp and imminent FDA decision it is still a risk. I would also suggest that if the sp doesn't start moving north in January then the risk is increasing. No matter how tight any negotiations are between MTFB and potential partner/s there will inevitably be leakage resulting in sp reaction. If
Thanks Ivy. No worries though as I fully recognise the need for and value of patience with MTFB. Despite the share price slump as we move towards February's FDA decision, I still have total confidence in the BoD so much so that I took advantage of the low price to add a further chunk to my holding last week.
I don't post much and when I do it's because I've found something particularly irritating or interesting about a post/s. I haven't had a problem with the recent arrival of the de-ramping crew as I'm a great believer in the freedom of speech on these boards as long as views are based on well researched facts. When the integrity of individuals is questioned, particularly when a poster is unlikely to have met the individual/s they are targeting, then I have a major issue. GL and the MTFB board have come in for a lot of unnecessary negativity recently as indeed you have on a couple of occasions. Spoils a good board for me.
The above may appear a tad self-righteous but meeting as many board members before and during an investment cycle is, for me, a vital part of my research. GL has been picked on for not being 'charismatic' whatever that means. One thing's for sure, I'd rather have some serious, dedicated, thoroughly professional individual looking after my money than a loud, back slapping, beer swilling joker of which there are too many in AIM companies (latter description slightly exaggerated but I'm sure you get the point!!).
Another key point about the MTFB BoD is the benefit of complementary skills on a team and it is teamwork rather than individual charismatic brilliance that generally leads to success. GL, JG and DH represent such a team. JG, the interim CFO, has also come in for negative commentary. I had a lengthy 1on1 with him at the last AGM (couldn't get a word with GL as you'd collared him!!) and it was well worthwhile. His contact within the Wall St investment community is exemplary. The spread of skills and contacts between the three of them is excellent and one of the reasons why MTFB has managed to get Iclaprim through to an FDA decision is because of this.
Anybody with any doubts about the BoD do check their CVs on the MTFB website but just as a starter. Then use that information to do some further digging. I'm confident you will be surprised/pleased at what you learn.