10Q, ugly.

Revenue: $28K, even lower than I would have guessed.

For the year, $46K revenue, over $3M COGS.

Still no start on MFG expansion that will take over a year to complete. W/o this, they are capacity limited to present sales volumes (revs will go up some, but are seriously capped).

I guess no CC this Q?

ARRY:

I do not remember the primary endpoint for the oxycondone ITT arm being previously published. Did I miss it?

I know most discount this drug, but if it really is as effective as oxy, and the QT issue is turns out to be insiggnificant, then it certainly could have some real potential.

Lol.::::::))))))
I am glad I could provide some entertainment value.

Question. Why is the remaining loan guaranteed by the Fibro Tech subsidy? If all Deerfield wanted was to insure that that asset could not be sold out, they could have put a standard "can not sell" clause in.

The reason why Deerfield share count rose to about 9% (please learn to read an SEC form) is from shares they recieved in excghange for debt. I would be 100% certain they would gladly walk with cash, but that option never existed, FCSC would just BK before payiog.

If your LOL comment is about me saying LaViv is dead, please. They have made no attempt to expand capacity beyond there 400 patients a quarter capacity. They knew this was needed over a year ago, but never acted. Why? because they know it is "demo ware". A product that looks good but is not commercial viable.

This wonder breakthreough product has been sellable in most of the world for 2 decades. In the US for over a year. They sold about $100K Q2 with a COGS over $1M (and that likely reliese and sunk R&D costs to keep it low). They have no plan to be able to sell more than about $700K/q at the best. And that can not make money.

Let's see what is up next Wensday. Should be fun.

MNTA: Reconsideration in banc.

Is this a reasonably quick process? The 3 Judges just present the case to the full circuit and they all vote? Or is another hearing?

At the appeal hearing it was obvious how the chief judge felt. And it seamed like the lady was leaning towards the decision made. I kind of assumed the 3rd would follow the very strong views of the chief judge.

I think this case is seriously underestimated as a potential value driver for MNTA. A win is huge any way you cut it.

Hopefully it is not "game over".

It looks like 9M shares to me, which is far less than 25%. The shares get multiply reported when in a subsidiary.

It will not even be close to 5% once the additional shares start flowing (though they do get some of these).

The real news comes in just under 2 weeks. The don't have nearly enough cash to get to the ASM (when they get more shares to sell). Maybe the can pull a rabbit out of their hats, but it is certainly possible that they will give Deerfield the house keys and walk away.

I honestly think that the "game plan" is to somehow spin off Fibro Technology (the supposed R&D side). That would be owned by Deerfield, the suckers that buy in, management, and a few token shares for the FCSC shareholders.

Then they can finaly let FCSC and laViv vanish into the night.

Anybody have a clue if the point value on pain reduction is decent (2.4 vs. 1.6 ; p = .027 vs placebo) is "decent"?

They left out the Oxy value (just said comparable), so I assume Oxy did better, but I don't see why that would be a major issue.

AMRN: NCE, what about isomers?

Seams like the decision as to a single isomer drug aproved over the racemic mix is exactly the same issue as DHA aproved over DHA/EPA.

And in this case the FDA has considered the single isomer to be not an NCE (the recent law changes that, but specifically calls out isomers so does not effect AMRN).

It seams quite clear that the FDA considers R- and L- to be seperate moities. The racemic mix approval is sufficient to make the 2 active ingrediants not elligible for NCE status if approved individually.

http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2007/06/fdara_single_en.html

This news might be more to the point: Fibrocell Science, Inc. Completes $9.1 Million Capital Raise

Yes, they were able to raise an additional $650k or so to complete the series E offering. This pays the rent through August (unless costs have been rising, which is quite possible as they have a negative sales margin).

The more significant "mews" will be the Proxy in the next 2 weeks where you will get a clue about forward dilution, and the next 10Q / CC where they will have to discuss the financial train wreck.

Re: CLDX

Short answer:

Potential competition in 2020 or so.

Long answer:

They discovered that the cell has some method of keeping EGFRvIII in check even when EGFR itself is overexpressed.

They theorize that drugs could act on this mechanism in onder to reduce the vIII levels. Since vIII is assoiciated with very agressive cancer, this might be a treatment option.

Why they are not mention of what maters is the actual product sales?
That number has been reasonably well known since the Q1 10Q came out.

Earnings are recognised about 1Q after the biopsy. Billing is at time of biopsy. Thus the unearned revenue (the amount billed but not recogonised) in a Q is a decent proxy for the next Q revenues.

That number implies $100k for Q2 revenue.

The number of biopsies was also known known months ago. They stated back in May(?) that the proceadures had maxed out at a run rate of about 130/month. So something in the 400 area was well known as the expected number for this Q. And next Q, and next ...

Expansion is "in talks with the FDA". So that is not going to happen until 2014. Of course the talks could just be an excuse for failing to act in the last year on something that (even if you beleive them) is needed to be gross margin positive.

HGSI: My view exactly. For a paltry $1/sh, couldn’t they have worked it out without the poison pill, the aborted tender offer, and all the nasty press releases?
But how much extra did management get in stock via all this?

SPPI: The long time longs report that fotolyn is used by the same oncologists who use Fusilev and is not competitive, ...

Is that true? I thought fotolyn was an alternative to high does methotrexate.The switch to fotolyn removes the need for leucovorin (of any form).

I certainly considered fotolyn a competitive threat back when I was an SPPI lomg.

Re IMGN853 and EC145

I don't understand the point about not being able to use the IMGN ADC for inflamation issues due to the target antigen. It seams obvious you would never use an ADC for such, regardless of the target.

For cancer, it works both ways. The more specific target may be better in indications where it works. Trials will tell.

Certainly they (Jim and Co.) provide more entertainment value.

They twice submitted applications that triggerd bonus payments, and then pulled the application so they would not be laughed at.

Their recent financing is state of the in the scam world. They sold off 20M worth of shares and warrents, but also it gives the "investors" rights to buy another $20M worth at some undisclosed price. Givin the price behaviour, it is almost a lock that this gave the "investors" cart blanch to dump the first tranch of shares ASAP.

But J.B. does dress well.

ARNA? I have never owned ARNA and have never seriously considered a position.

Sorry, I mistyped that one and meant to say ARRY. I do hope I got that right from memory or I will just have to go back to watching hoops

EDIT: I don't feel as bad as the one time I type INGN instead of IMGN. That was REALLY bad!

Because Alan Auerbach is so good he can just make the damn drug work?

Because all the N.England biobucks are betting on him because they think he is Red's son?

Because W.C.Fields was right?

I will predict right now that this could easily become the most over-hyped joke in the history of bio tech.

EDIT: P.S. to mcbio, I hope your ARRY works. It just bubbled up to #3 on my holdings somehow.

To clear up one detail, the material already provided that was redacted must be provided unredacted. The suggestion about allowing a private glance applies to future documents so that they do not have to ping pong through the courts.

Two questions for the lawyer dudes (and note how we are more polite when we need your help )

When the court ruled on motion to provide unredacted docs, had the court already seen such?

Is this "suggestion" a fairly standard concept?

DNDN banned tape recorders and cameras at annual meeting, according to Luke Timmerman. Company still has paranoid mindset, evidently, even with new management.

And I guess they do not understand the capabilities of smartphones?

I would suspect more of a security issue.

There have been case in the past where hackers have grabbed accounts and used those to trade into other positions in a thinly traded stock.

OMTY: I personally dont buy the SOC arm is living 36+ months theory

But I also do not buy into the theory that the IA2 alpha spend was something like 1E-7.

Which kind of presents a problem. The combined curve is well enough known that it should be pegged down to within a few months. So there is simply no solution which will pass all smell tests unless we have our "facts" wrong.

The only theory I would toss out (that everyone else does not agree with) is a massive data collection failure (particulaarly in less developed nations) due to the halt. Of course that could be as absurd as many other "explanations" that have been tossed out.

Regardless, that something is likely "wrong" is not good. Stim could of course work, but the blind "it must be working because it has gone this long" logic is certainy wrong.

CORT and CYPB. There are probably another 1 or 2 that I just couldn't think of off-hand, but the larger point is that it is rare that everything comes together in such a way as to allow us to figure out what went wrong.

I somehow suspect that ONTY will get added to this list.

Have no clue if that is good or bad for ONTY longs. Just that I think there is a big unknown that will come to light next year,

Nevertheless the adjusted hr of 0.58 in the no squamou subset still makes the final a good long bet

Was the analysis used to come up with the adjusted PFS HR pre-specified?

It was certainly a lot better than the unadjusted number.

All the lawyer types seamed to say 2-4 months, so we are going long.

I will predict that the top dog on that court wants to write a really definetive peice on the Waxman-Hatch exemption.

Furthermore, I will predict that aspect tries to limit the W-H exemption to what was clearly intended A generic developer can use the patatend drug while pushing the ANDA. That is it,

I will take all bets on this one

BTW, this likely has nothing to do with the case at hand. They presumably have decided for other reasons (hopefully lack of irreparability) that the injucting will be lifted,

Re: TB Quiz

Are they really restricting the drug for the common good? I would be impressed. [The cynical me wuld say they are just saying this for the time being to make it harder for others to grab this market.]

I think antibiotic abuse is something where the State agencies have really failed. In much of Asia, ciprofloxicin will soon be a placebo.

I have no argument that it is a different data set.

But I would really like to hear a rational explanation of the "every treatment option" issue If taken litterally does that mean that every patient in the trial had to fail every option? If one fails one taxane do they still have to try others?

What are the rules? And why?

EDIT: I do own a chunk of IMGN, but I profited off this decision. So I am not grinding an axe.

Ok, they dodged they debt issue. Almost a given as one could safely assume none of these guys actually want the company. Let us take a serious look on the financial side though.

They expanded the shares (counting converts/preffered/warrants) to almost 300M. This is something like a 4X dilution in a year. And much, much more to come soon. W/o a reverse split it will be over 1B within a year.

They are capacity limited at about 250 biopsies/Q. They can not increase this w/o capital expenses that they have not funded in 9 months now. Scaling up the lab is not enough, yet they have not even started on that. They once estimated $20M for a real facility, and they are scraping up cash to keep the electricity on.

But maybe this is all just a cash issue, and the stuff is really wonder bread.

Problem is that once more they have negative sales margins. They have "solved" this minor issue three times in the past, and are trying once more.

Hint, their game plan is clear. They will spin some sort of "fibro stem stell biotech" soon. management and Deerfield etc. will be in on that. Shareholders in FCSC will be left with a corpse.

CRIS: Response (%): complete 0/3, partial 0/11, stable disease 49/31. Median PFS: 3.7/2.4 mo (95% CI: 2.4-4.6/1.9-3.7; adjusted HR 0.92 [0.52-1.64]).

I don't get it.

Is vis. actually preventing the responses that the gemcitabine would expect to cause?

Or was this just a really bad hair day?

Or what?

Re: CLDX and Zebras

The funny thing is that I really wonder if Rindo is the real Zebra in CLDX's farm.

On the serious question of how to go forward with '011, this will clearly be absolutely driven by the numbers.

Number of dollars that is. If they do not partner, they need the clearist and cheapest path to approval, even if that is a smaller indication.

So 19M more shares for 2.3M$ (actually a better rate than I would have guessed), still nowhere near enough to pay off the debt due next Friday.

As to "untill revenue picks up", they clearly can not make a profit at this level of sales (even ignoring R&D and S&A). And manufacturing it capped out, with no ability to increase it for at least a year or so.

So how do the finacials play out?

A) What do they do with the debt. 50M more shares could cover that if the debt holders agree.

B) That gets them to about the end of July or so. What then? More blood money?

C) How do they ever get profitable if they never expand? They claim they can become cash flow positive at a level that is well past what they can make in their lab even with a new incubator. That is not going to happen until 2014.And they stated back in July '11 that they would need something like 20M to rampof to commercial scale. Is that another 2 billion shares?

Seriously, do you realize how bad the financials are here?

Perhaps a cute play on words wrt the EU (political) stability issue?

They say they now have all the data to resubmit the RTF'd NDA and it will be in the mail by early August.

Be warned, they have been going through records over the last decade to collect the missing safety data. And the trial was long since unblinded.

Re: CLDX '011 in TN

It looks to me like the results in the TN vs non-TN groups (both overall and HG) are being driven by the IC arm performing worse in TN rather than '011 arm doing better. '011 is more effective in HG, IC is less effective in TN, and the results make sense.

Both IC and '011 are somewhat effective in the non-TN/LG population so those results were bad (likely even trending the wrong way). As we move to TN the IC losses effectiveness, while '011 maintains it's effectiveness. As we move to HG '011 becomes more effective so the relative effectiveness is greatest there.


If such, this also reflects and your assertion a while back that the TN/LG non effectiveness might bode poorly for the TN/HG relative effectiveness. If IC was a placebo and the TN/HG results were driven by the sum of TN and HG (I don't mean that literally) I would agree with you. But when driven as I assume they make perfect sense.




Hell, I am neither a good scientist (nor investor), and my post-hoc explanation seams excellent to me

Yes, Everidge was approved on a small single arm trial. But the endpoint was ORR, not PFS.

Dr Garren is claiming a single arm PFS endpoint would work.

What would an FDA stat guy consider a good PFS value in a single arm trial? I would really love to hear a rational answer on that.

My answer is none. The FDA will not accept PFS single arm, period.

Yeah, response rate is OK in a single arm.

PFS (and even OS) is not because there is no way to evaluate it.

I can certainly find an example where the FDA would not even consider PFS data for exactly this reason (in a very similar setting). Can anybody name a case where a drug was approved on PFS single arm?

Wow.

Does not the FDA clearly not consider time based endpoints in single arm studies for registrational purposes (even accelerated)?

Who is smoking what?

CLDX: Re: Herper's article on '011

What was so bad about it? It seamed like he hit 3 points:

. The ITT results were unimpresive
. Subgroups looked good
. Numbers were small

He opined that it could well be strong enough data foir the trial to go into further trials.

That does seam to grasp the core issue.

Yeah, the headline was a bit snappy, but he writes for a real magazine that sells the stuff.

Back to the real topic, is ther a decent chance that some of the unconfirms are just that the data is early? They said the data was incomplete and variable (OK, I know that can be spin) which could imply that some could become confirmed over the next few months.

Seeing some durrability in those response would go a long way to making the data a little more clear.

Darn.What am I going to do with all the physical-gold I have been hoarding in my closets?

Relax, this is just another case of bad science. That the 8th century Mayan's had "a sophisticated knowledge of astronomy and mathematics", in no way implies they had unlocked all the mystic secrets of universe as they would do a century later.

Your gold stash is safe.

BTW, where do you live?

Re: Demand

I would consider this to mean the entire curve of price vs. quantity.

We know the supply side curve quite well, they are maxed out at something like 300/Q and can not increase that until sometime in '13 (extra shifts do not help when the bottleneck is the incubator).

If there is plemty of demand, why not raise the price? As a start stop giving them away free.

Of course the freebies will fly out the window, that is a no-brainer.

Plenty of demand would mean that they could price this at $5K or more to FCSC (which might gather positive sales margins). Not price at $2k (which is a loss) while giving most away free.

Maybe you are right and this stuff is great, but to ignore the financials is insane.

find it easier to use the median OS

If the situation really is represented by constant hazards then:

. The "average" (mean) is almost 50% more than the median, so you need to adjust for that.
. In small trials, there will be more "noise" in median than the HR (the best measure).
.Mean would be better than median, but obviously has practical issues.

If the "true" curves are not constant hazard, then median can be a very poor measure. Suppose a drug completely cures 40% of people with an otherwise quickly fatal condition? The median improvement would be trivial, but it is 40% to save your life.

I was not stating what that caller asked. He was asking if the remaining shares would go at the rate of 20s/$ or so (based on Tue $3M an 65M shares).

I do realize the "ratchet down" of the series D is done, and any more shares at this price do not cause further outflow there.

But these shares will still be at $.25 (hopefully for them) along with 100% warrants on the side and fees(that was also part of Duncan's reply to the caller). And that makes for an effective dilution of about 9s/$.

So the numbers are:

65M shares dilution Tuesday

Another 80M shares (9M * 9s/$) to raise the rest of the 12M

Another 60M shares (6.7M * 9s/$) to cover the debt.

And that gets them to Q4 (unless they really ramp up, in which case it could run out by end of Q3). So they are back to the well then.

And guess what? The series E shares just sold have the same "ratchet" in them.