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Why the hell do you guys bother posting on here? I used to read this thread everyday until last year. The company is done. Do something productive for ****s sake.

Yes, expensive to develop new drugs of course but the sharks are circling MTFB and it would be nice if the world of capitalism were filled with gentleman but that is a fantasy land filled with unicorns and fairies. There are many companies probably looking at it thinking, "if no funding comes in over the next two months, this will go bust and we can buy the IP for a song." The value of Iclaprim long -term (if approved) is not doubt valuable but it is crunch time so for all the "it costs $1 billion to develop a drug" talk is totally irrelevant to the present situation given the trial that needs to be conducted and possibility it will never become an approved drug. No company that would buy the IP if MTFB went bust is going to pay within a galaxy of the cost of bringing the drug to market. Think a dumpster fire sale. They will say "thanks for spending a ton of money on all the heavy lifting but we'll take it from here at a tiny fraction of what was spent to get it to where it currently is." I remain long and upbeat that a plan will be put together but I'm very cognizant that vultures are called vultures for a reason.

Andrew Powell needs to pull off a hail mary and right quick. It all rests on their ability to pull together funding from a partner(s) and damn fast. The insanely tough part is how do you convince a partner(s) to put up funding for a trial the size of which you don't yet know or if it will even be approved by the FDA to proceed. They can always say "go back to the drawing board and come up with another approach." Yesterday's RNS was good but there are a million more potholes still out there. If, by some miracle it does get pulled off, this will be one of the most impressive feats I've seen in my investing career. I hope to hell it does too.

Thanks for the note Jackdaw. Yea another phase III trial makes little sense but I can't shake it given how we were successful before in two of them, submission of NDA with no issues, no Adcomm and then get shafted. What you said makes sense regarding a smaller subset trial. If that ultimately is the case and funding can be secured, MTFB is the best buy on the market and will rocket. We'll know soon enough if the FDA wants to destroy a good company and delay a much needed drug. Cheers,

We know another trial is certain so the bet is essentially this: Do you believe it is another phase III trial or a smaller subset ?

The wildcard is that if it is a small subset trial, the drug is likely as good as approved. Highly likely to get funding for this. If another phase III trial (makes little sense but it's the FDA) then stock is likely toast despite being closer to the finish line than ever. I'm inclined to think it's another phase III because if they had concerns but not serious ones than they would have done either option 1 or 2 of GL's scenarios. In that case, the company is probably finished and the drug will end up elsewhere for who knows how much.

We also have to take into account a partnership and cash injection being done but only because we can't rule it out. I'd put that at a low likelihood but you never know. We are basically certain that they had partners waiting if approval happened. The big question is if those partners took off or GL and crew are pulling out all the stops trying to work perhaps a consortium buyout to spread the risks. We cannot rule this out but just don't bet on it happening.

We have cash until September and as of now, no news released regarding a future plan for anything. Is it likely a white knight will come save the day? Anything is possible but I certainly would not bet on it even given how close this is to potentially being approve. If you are a lender, you are looking at a company that will be bust in 3 months and a valuable asset that could be sold for pennies on the dollar. You have a company that needs to submit a trial plan to the FDA that may or may not even be accepted to begin with and even if it is, might not be successful. You also don't know the cost, size,and scope of the trial. It's an awful bet for a lender unless you have a group of funders that put up cash for a giant chunk of MTFB. In that scenario though, the Company would have to give up such a giant part of itself that it would be like diluting themselves to hell anyway. I suppose the optimists might think that a group of buyers could swoop in and buy the asset at some sort of reasonable valuation if they believe that if they wait until bankruptcy, there will be many interested in buying and bidding the price up too much so if they act early, perhaps they can get a better price.

It was a good shot but the FDA in their infinite wisdom, decided to shoot it down. If you re investing now for the first time, it is an asymmetric bet on a group buying them out at a higher price. Not an awful hand but not one I'd take. If you're like a lot of us in at much higher prices, you're just trying to ease the pain and be realistic. The Company is likely toast.

Anybody want to take a stab at what kind of trial this will be? another phase III? smaller subset trial? Either way it's a long slog from here.

It could be 30 business days so that would take us to June 14th.

It is not uncommon for companies to no longer have a conference call webcast on their website after 30-60d days. Some companies leave it up some dont. I remember GL saying we are seeing no indication new trials are needed but he never said new trials are definitively not needed. You are reading too much into the removal of the webcast (which as mentioned is not uncommon) to believe that new phase III trials are certainly needed. Would you want to place a short bet based on that info alone? Most on here are betting on option one or two given the two successful phase III trials and how another phase III trial likely wouldn't tell us anything new. If option one or two is required we have approval, rerate, likely partnership, no trouble raising cash, etc. Most like differing points of view but yours don't hold a lot of water.

The problem with investing in biotechs is that we are using logic to apply a set of probable outcomes but we are dealing with an often illogical entity in the FDA. It's like a student that passes all five tests in a class (for mtfb this is phase I, II, 2 phase III trials, and the submission of the NDA). The teacher gives the student passing grades on all five tests leading the student logically to believe that they will pass the class. When the time comes, the teacher fails the student telling them they didnt like an answer on the third test and to go back and retake it. The student is dumbfounded about why the teacher didnt fail the student the first time around. That's where we are with mtfb and the fda. It's hard to see the fda as capable given all the data and successful trials we have had. Now it's possible we will have to go back and do a 3rd phase III trial which, could spell the end for the company, or not of course. We'll know soon but I am now of the belief that after holding for 2.5 years, the company could very well be at its end if another trial is required. Hard to see the fda as highly competent at their jobs given how they approved all these toxic opioids destroying lives yet they might destroy a greatly needed drug. At some point you have to accept that the fda is an illogical entity and can deny approval for a drug based on a concern that we look at as entirely acceptable. The fda is sure doing their part in exacerbating the antibiotic crisis. Sorry for the rant but it's either this or fall into a bottle.

If the news is good what will happen to the stock price? A re-rate. Yes, the market knows that MTFB needs cash but they would also know that a path to approval is laid out and looks highly probable, thus the company could float shares at a much higher price.If the news is good the stock price would not drop or be flat because the market knows they need to raise funds for a resubmission. It would be viewed highly favorably because the probability has just increased that the drug will get approved.

scott-If the news is good and the path forward looks fixable within say 6 months, the company will be in a very favorable position to raise cash. Markets punish stocks that raise when the stock is in the toilet and reward those that raise when the stock price is high (or in this case potentially) a path forward looks fairly straightforward. They would be able to raise whatever they need which would likely be not too much to the next submission of the NDA and a second PDUFA date. If it gets approved then a partner is likely waiting in the wings to provide funding for commercialization and then, we are off to the races.

and the conspiracies are flying on no news of course. It's folks using the February crash to continue to extrapolate that into every down day as the sky is falling. We won't know anything until June so stop chasing the rabbit around in your head about the company and Lumsden. The incessant blather about him is turning this board into any other board filled with day traders and charlatans. " Some say he is leaving the company yea yea I heard that too. I heard he was spotted on a boat bound for Argentina. I heard he was spotted near area 51 aliens in tow at a gas station. " He and the TINY team have done a remarkable job save for the lack of contingency planning. The FDA asking Motif for additional data just before the PDUFA date tells me the likelihood of it being a minor issue is high. Certain? of course not but that is how it looks. I'm betting that whatever the issues are they are fixable over time. Stop fixating over the daily stock price and using a down or up day to determine whether or not Lumsden is fleeing the country or deserves to be knighted. Focus on what we know and forget about the noise.

You could just as well argue it's about instilling shareholder confidence. They have only had a brief conference call shortly after the CRL and the most recent presentation in Amsterdam. They know shareholders want more face time with the company even though they cannot divulge non-public info. Just saying "it won't get approval" rings hollow. Give me some data points, do you think it won't get approved because of the science? Or are you using recent bias based on the CRL to now say "see, they got a CRL and therefore this is game over." The FDA contacted them shortly before their decision and whatever they responded with did not win over the FDA. Now, if this were a serious issue would the FDA have waited until after phase I,II, two phase III trials, submission of the NDA, and no ADcomm to tell them there is a serious issue with the science or safety? No. This is something easier to solve but nonetheless still a hurdle. Continually stating they haven't bought any shares blah blah doesn't mean the drug will or will not get approval.

Indeed, it certainly seems that if whatever is required is relatively easy to fix, that this could be seen by the market as an early approval by the market much like a favorable vote in an ADcomm. Adcomm's are no guarantee of course but I'd put easily correctable issues in this same box. If that ends up being the case, we'll see a re-rate of sorts. The big question has always been about a potential partner. I'm now convinced they have one or perhaps several lined up. Not sure if they are waiting until approval to announce (if approved) or perhaps given the CRL, they will then release info. about partners after the minutes are released if it is positive. A lot of variables at work here but given the late request from the FDA in January regarding liver toxicity, I do not believe it's anything major. They wouldn't wait for 3 trials, an NDA, and have no ADcomm to announce a major issue with Iclaprim. If we were binary before we are super binary now if that makes sense but I believe this will be a home run in due time.

Hi Ivy,

I think that's a good guess. Given that the FDA brought the issue of liver toxicity up with them in January, I can't imagine it being a big problem. If it were, it would have been brought up much much sooner. A labeling issue makes sense and if that ultimately is the case, I believe the stock would re-rate perhaps to a level higher than just before the CRL was released.

Antha-Not sure how long it would take if it is a labeling issue to resubmit but certainly the preferred setback opposed to trials.

This CLR just makes no sense. MTFB put through two successful phase III trials with Revive I and II. The NDA was accepted and there was of course no advisory committee meeting. If the FDA had any reservations about Iclaprim, they had two trials, an NDA, and could of had an advisory committee meeting to address it and they didn't. Does any of this seem logical? The FDA had four chances to fail the drug and didn't then the liver toxicity issue comes up seemingly out of left field?

What can we take away from this? Does it seem probable that the FDA would require an entirely new phase III trial given the two previous successful ones? It certainly doesn't to me and that leads me to believe as was mentioned by Ivyspivey and others that it could very well be a labeling issue. We don't know the specifics yet but a fund raising is likely in the cards.

Redbus-They will be hoping to get a meeting with the FDA in 30-45 days. Approval is not even a remotely accurate possiblity in 30 days.

I believe you have done research on the company and I find your postings somewhat needed so we don't fall into group think here which happens a lot when blind optimism occurs. The market for AB while needed, is just not a giant revenue generator as evident by the big boys fleeing. We're looking at a good little company with a great AB but investors here (myself included) need to be realistic and adjust your expectations. Talk of a $ billion dollar revenue generating company is short of insane but 2~300 million over many years? Possible. The lack of.conservative and rational expectations on here is a bit nuts. Look at the industry and what is happening rather than broker notes that nobody takes seriously. I've been long for 2 years and believe strongly in GL's leadership and management approach. If, however, they don't get a decent partnership signed the stock is toast and if u do not understand that then you shouldn't be invested here. Approval is essential of course but largely priced in. Petch understands this and also seems to understand the industry as well. I remain long here but also find some value in his postings bringing sanity to the often rose colored glasses some here have. Adjust the what the industry is telling us and have rational expectations.