The constraints of the a blocking patent are conceptually another thing - perhaps a different thing physically. The answer to that is something the court may opine.

No perhaps at all in this. Here is the Copax lable description:

That comes out to 4.49:1.48:3.56:1, which is not 6:2:5:1 in my book.

How well this argument works in court is one issue, but it is obviously possible for mC to have the same molar fraction as Copaxone but not the described 6:2:5:1.

[BTW, the 6:2:5:1 relates to copolymer-1 in general, not the improved version. So this might not be a very strong argument if the process of excluding the big chains somewhat shifts these numbers]

MNTA: Treble damage criterion.

Here is some info on what actually makes for a decision (once you get past the obvious).

From this:

That point will easily go to MNTA/Sandoz, as they would obviously get a legal opinion before launching (and would certainly not ignore an adverse opinion).

Some other factors listed here:



Most of those elements would also lean in favor of MNTA/Sandoz. The deliberately copied clause might go for TEVA, and the defendants financial condition would go for TEVA.

As this is a totality of the evidence situation, I think that the issue is not even close (assuming Sandoz does not override their lawyers opinion and launch regardless).

But he fails to mention OS.

There are certainly many genetic mutations that both reduce life expectancy and risk of coronary arterial disease.

PCKS9 might very well be real, but I would not trust this Steinberg guy for one second.

Re: CLDX - CDX-1135 value

Well, DDD is rare. I have seen 2-3 per million.

That said, a similar drug, Soliris, is getting over $400k/year per patient for a more common (but still rate) indication.

http://www.forbes.com/2010/02/19/expensive-drugs-cost-business-healthcare-rare-diseases.html

So if DDD is it, we might see $30M/year for this drug (if it works as advertised).

The real question is does it have a use in any other auto-immune settings. I have no friggen clue.

Still pissed about ZGEN?

SGEN:

Agreed that it is the ballpark, but it does look to be pricier than the others (though I don't now what the mean number of cycles for Rev would be).

Given the effectiveness though, I would not expect to see a Provenge like push-back.

SGEN: Acedris prices at $13k per round

Up to 16 rounds, with a mean likely over 10 rounds. Kind of expensive.

MNTA: Re. the trial date decision.

Maybe we need one of our lawyer pals to chirp in here, but I would think it very likely that the Judge set the date based on input from the two parties.

So there might be almost no difference between "the parties agreed" and "the Judge said".

SGEN ... with a favorable label

I am a fanboy of SGEN, but this label surprised me. All they had to support the non transplant crowd was 20 patients in P1 trials. And most thought from ODAC that the FDA was nixing that part of the indication.

The label could get them to break even by Q4, which would certainly help the stock.

Hope it helps, all my brokerage accounts are on life support. Bleeding red.

OT: CTIC up 20% today

By a quick calculation, the same amount of cash would have bought about 2.3B sheets of Charmin, both softer and does not suffer from reverse splitting.

It's not always just paperwork (mostly electronic now of course). There can easily be minor pre-clinical and CMC items that actually need to be done (not just documented).

But on the paperwork itself, somebody who had actually seen a paper submission in the old days said it was 3 feet high. I imagine back then it could be a full time job just tracking the paper.

Kindler -Incredible.

The only thing I really found incredible was that the head of H.R. was in any way player. That position should be a minor function under the COO.

As to the corporate politics, that is not surprising. The "C" titles in major corporations are no longer about doing the job, it is about getting the gold.

TSPT:

I did read it.

That there might be several addressable issues does not change the fact that one item looks very bad,

The FDA wanted the TSPT to show that the drug did not impair driving if taken 3 hours before waking up. TSPT submitted trial data, and the FDA said that it looked like the data suggested it DID impair driving.

It is VERY hard to dispute a safety issue once the data suggests it.

BTW, remember that all you are hearing is what the company is saying. The actual FDA letter could be much more clearly damaging.

TSPT: Intermezzo faces a tough road.

In the earlier CRL the FDA raised the issue of what would happen if the drug was used with less than 4 hours remaining. To address this TSPT ran a driving test with just 3 hours sleep after use.

The FDA did not like what they saw. "In the Complete Response Letter received today, the FDA stated that these results suggested clinically meaningful impairment. "

The only hope they seam to have is that the dosage is too high for some. But to resolve this means going back to square 2.

FCSC:

In 6 months you will see several hundred treatments. The argument will then be that is is supply side limited (a theme for individualized biologics).

The cost will be very fuzzy, as at that level they can leverage the R&D side to avoid costs (almost no depreciation left on the lab stuff). But even so, they will need more cash this winter (unless they elect to not expand at all). If they try to launch for real, you will see the cash flow blood red.

Vinorelbine?

BTW, I assume that DD's "most useless" drug comment was that since vin is rarely used in the indication, the clinical benefit of Exelbine might be to eliminate something like 5 injection site reactions a year.

But wait!!

If you come back next year we can try the same scam with an emulsion form of some taxane.

The is no friggen "quiet period".

The company may elect not to discuss certain (or any) issues. But there is absolutely no such thing as some law which prevents FCSC from talking due to some partnership / merger deal being in the works.

Given the recent financing, it should be fairly obvious that there is also no deals in the work.

They have not been talking because they elect not to.

It's R&R (everybody other than janitors and secretaries) that needs to be wearing orange jumpsuits. But that will never happen.

The big boys get bailed out, the middle guys get ignored, and home ecc. TV personalities go to jail.

The only exception is when somebody like Madoff f's over many in NYC.

Still just an epidemioligcal study.

Is there just more natural variation in DHA that causes it to show non stat-sig (despite a solid HR)?

Is this just that some people watch their health and this drives all 3 variables?

Question, if a patient comes in for Provenge and they go ahead and manufacture the dose, then the patient does not take it.

Who gets stuck?

And an even clearer case for calling BS on this excuse, DNDN could easily float the cash for a few month for chump change.

That would be a lot better than a scale back on all counts.

That bring up another item for the "Newby Mistake" list.

When Rodman & Renshaw issues a puff piece "opinion", that is not good news.

I guess you now are identifying some demon spawn of R&R.

A real question though, how easily can we gain by understanding this crap? It is just often so hard for retail pukes like me to short the stuff R&R is selling.

Skipping all the trial issues, is there a real chance that the artificial tear product was (at least in some cases) preventing the natural process from ramping back up?

The patients had a bout of dry eye, so started taking the tear in a tube. Somehow the system sensed this, and no long produced sufficient natural tears. They enter the trial. The washout did nothing to change this, but afterwards going "cold turkey" allowed the natural system to ramp back up.

Kind of analogous to taking testosterone and the effect on one's testes. To restore normal production all you need to do is remove the external version.

OT: We now have the "DD for Congress" fan club!

Go for it Mr Smith!

Not certain if this means that they just want to get rid of you though

That all makes sense, and is how I would view it.

But I think BTH really has a more specific issue on his mind, ARIA's Rida. which was first developed as an IV formulation then replaced with an oral version.

This one has me confused as well. It seams more reasonable to go forward with the IV unless there is something we all are missing.

Is the convenience issue that big?

Reporting from Bangalore?

It is the Silicone Valley of India. You will see a modest amount of news come out of there.

OT Rant: RE: SHO

Not quite, any positions established before the stock went on the list are exempt from close out. Also, the "penalty" for failing to close is only that they can no longer short w/o having firm borrows.

Do you really think the SEC is going to put teeth into rules to protect retail scum?

I really think this is a minor issue, but Reg FD really annoys me.

It would be easy for the SEC require that all communications covered be made over open e-media. Regulation ED instead of FD. Simple and easy. But no, we now have rules in place that allow analysts to get answers that you will never see.

If anyone thinks the SEC is out to protect them in this area, they either do not get it, or have about 1000X my net worth.

How does that POS CTIC still carry a marketcap of roughly 300 million??????

Because they cant find a way to scam it up to $500 million

Seriously, I generally do not go with all the vodoo stuff, but I think there is clearly a game being played with the stock using the Milan exchange. Just have no clue what it actually is.

Could just be a huge illicit short that is being covered over time.

I would be curious to find out what company trials are in the removed parts of the FDA letter

If this was Vegas, I would place a bet on CTIC to be the "winner".

They always come up on any discussion of screwed up trials.

Re: Cost

I am not clear why the London numbers are not a decent starting point, but we will take another try.

Let's consider everybody favorite comparison in the land of biotech stocks, DNDN.

There are some key similarities here. The Provenge process extracts cells from a patient, manufactures a patient specific batch of the drug, and ship 3 treatments from that back to the customer. There were some fears that this would be too expensive, but DNDN was able to show otherwise.

The Provenge COGS number is presently around 50% of sales, but they claim this should drop to 20% when it hits full volume. But that is still $18K of cost for the 3 round treatment.

Is Provenge that hard to make, or is it just the "individualized" nature of the process? According to the FDA it is more the latter :



True, they are talking complexity not cost, but they often run together. DNDN does have an extra cost for purchasing the antigen, but this is not that large.

So we have 2 data-points (the above and London) that tend to support the position that LaViv looks very expensive to make.

The only number I have heard on the flip side is the cost of a flat panel TV.

ONTY:

They were enrolling about 45 patients a month at that time.

Re: Merely doing a financing will not solve FCSC’s real problem,

You miss my point. They obviously need cash within a month or so.

IF the cash comes from a partnership or other real investment, then one can presume that somebody with more open access to the books is willing to bet on commercial success.

IF the cash is a few million of warrant laden crap, then one could assume they could not find any real party who agrees with the commercial value of LaViv.

ONTY: I dont think this guy is the most ethical guy around.

No argument.

But how far different was his piece from the one several days earlier?

ONTY: Clark or P3, do you guys know how the trial stop and patient "replacement" is being handled? The first SA article that started all this ad 2 different claims, and both seamed bogus to me.

Are you guys assuming that the extra patients are just to make up for the loss of power created by the known protocol violations, or are you also assuming that based on some rule patients have been removed from the ITT population? Also, were the peek points (and final N) adjusted?

On a related item, how many drop outs do you guys model at the trial stop?

Why do you guys need to wait a year to know the story?

Within about one month FCSC.OB will either:

1) Get real money either from an investor or partner.

2) Get "bioscam bucks" from the low rent clowns that R&R deals with.

3) Go BK.

If somebody wants to bet, then the demark line between 1 and 2 could be an issue. But for general validation this should tell the story fairly soon.

CLDX: As long as we are talking about Hammer's picks, what do you guys think of that CLDX?

2 mid stage drugs that could work, and their APC technology (using antibodies to deliver antigens to dendrite cells).

Seams like a reasonable shot at $120M.

Nope,I am obviously not the Baron K. dude.

I would be smart enough to copy posts of DD, Clark and some others instead of myself.

OT: "Winehouse had talent"

Yes, she did.

I would note that one song of hers that almost all know, rehab. says a real lot about how this played out.

NEOP: To garner approval there is no regulatory need to run a trial against the SOC.

The FDA is not tasked with determining that a new product is as good or better than existing products, just that it is safe and effective. And this is how it should be. There can be many reasons why different product exist on the market with varying effectiveness. It is up to the docs/patients to pick the right one, not the FDA.

So the fact that Lymphoseek was trialed against blue die w/o silver collide would not in itself preclude approval. If that was all of Marty's argument, it is week.

What this bodes for commercial success is another matter, and I have no opinion at all there.

Thanks for reminding me about the citizen petition, a good laugh is always appreciated.

NEOP:

Yes, NEOP has a high tech product for imaging in the lymph glands that will have to compete with some old tech (silver collide products).

Suggest you just continue to ignore this act.

[From memory, not a company I care about either]