St Valentine's Day Massacre Mk.217 Feb 2019 18:35
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.
Sign In
Follow the stocks
