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... I'd like answered
"Does the BoD believe that there is a significant 'liver toxicity' issue here and that subsequent clarifications will address FDA concerns"
Based on trial outputs, it would seem not, but I'd like to understand the current BoD levels of confidence - do they trust the work put in over recent years to get this over the line - or not!
Doesn't it just. Lets hope FDA official see it as well and come to the same conclusion.
At 25p I’ll only end up having to donate one leg and not the shirt off my back ??
Agreed, all we need is some positive news to get this moving in the right direct. Sentiment will also change, and the doom-mongers with any luck will go find another carcass to pick over.
... the wind has changed direction...?
Short term financing sorted?
Hi Juniperst
Thanks for sharing your insight. In your experience then will FDA have communicated their specific concerns to MTFB following, or as part of, the CRL response? As it stands everything remains very opaque!
At possibly something in the range of $100m, which translates to about 30p per share - it might put us all out of our misery.
That said, I would prefer a positive update within the next few weeks saying that the FDA are happy bunnies with the application. In fact, if I'm totally honest, I would just like any form of positive news.
This may well be the case, but the thing is, there is not a single person on this board, who has any real idea as to what is going on, even our resident experts seem non-plussed by recent events!
GLA
At last, added a few, fingers still crossed
... Just as I want to buy MTFB this morning following the shake, the III site is down!!!!
Whats it looking like this morning?
So $100m is worth in the region of 25p per share at current exchange rates???
Good morning Ivy. DO you have a view as to current MTFB value, and are you able to respond to my email below with some extra insight as to the BoDs confidence that this can be resolved,etc?
FWIW, I would like to understand what the value of the drug actually is today, having passed 2 P3 trials with seemingly very positive results and nominal side effects. Also, of course, this wouldn't be a one application drug.
I would also like to understand what the detailed nature of the apparent questions that the FDA put to MTFB during January regarding Liver toxicity and whether its these that need further clarification. If so, is the BoD confident that it is able to address these concerns.
I'm guessing that there have been discussions with remaining II's already. If so, there remaining ?onboard? should be seen as a positive sign, but in all honesty I would like more than positive signs, I would like a more detailed insight into WTF is going on, and is the BoD not just confident, but able to get this over the line. If not, maybe selling out what we have at the moment is the best option. If so, what price?
GLA LTHs
"It has become a familiar story: a drug developer promising to find a treatment for a hard-to-tackle disease crashes at the final hurdle. This time, it is an AIM-listed company working on a new antibiotic for acute skin infections.
Motif Bio’s management, led by Graham Lumsden, claimed that the drug iclaprim had shown great promise in killing specific infections, while minimising the growth of drug-resistant bacteria. Last month, broker Peel Hunt sent a note to investors praising Motif Bio’s “de-risked product” and “undervalued pipeline story” (groan).
That statement now seems somewhat premature. On February 14, the company announced it had received a “complete response letter” from America’s Food and Drug Administration (FDA) in relation to its drug, which had passed two phase 3 trials. In effect, the FDA needs more information to allay its concerns over the risk of liver damage. It could demand further testing, which could take months.
Shares crashed 88%, leaving investors including Invesco — which dumped 10% of its holdings — and HSBC nursing heavy losses. They closed on Friday at 7p, giving the Motif Bio a valuation of only £20.8m.
The company remains optimistic, saying it will discuss paths towards approval with the FDA. However, investors should take note: it is not the first time iclaprim has been at the sharp end of the FDA. A decade ago it was in the hands of Arpida, a spin-off from Swiss pharma giant Roche. Arpida was forced to lay off most of its workforce after the FDA’s advisory panel denied iclaprim approval. A few years later, it was back — this time in the hands of Motif Bio, which raised $10m (£7.7m) from investors last May in expectation of approval. However, the FDA’s concerns over liver damage are a red flag — drugs have been pulled from the market for less.
Motif Bio is now in a precarious cash position, with just $3m left after being forced to repay its specialist lender, Hercules Capital, $7m last week. Lumsden has warned the company will have to raise more money.
Some say Motif Bio should put iclaprim out of its misery. “They should have killed it the first time round,” said Andy Smith at Edison Securities. “Management should sell the company and get the hell out.”
While it may sound drastic, Smith has a point. Investors might do better putting Motif Bio up for sale — allowing a private company to reverse into it and take advantage of its tax losses. It’s either that, or be asked to plough millions into a drug that may never make it to market."
England and should be a cracking match...
and lets hope that the delay here is nothing major and that MTFB converts their try at the second attempt.
Pebs/Vasc - Trials resulted in zero Liver related and kidney related deaths, plus no long lasting effects given the course administered. Vancomycin on the other hand resulted in 7 kidney related deaths. I know which product i'd rather have, don't you?
I really would like to understand the nature of the concerns expressed, but nothing in the public domain supports anything major, IMHO.
Now for an afternoon of rugby
More importantly than your english can you elaborate on the January 'Liver toxicity' call :)
Really? Do we know the nature of the questions?