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I wish I could find some reassurance (other than Dr. Cox's purchaces) in this post. I guess it beats widespread selling....bp
Dew, When Wolshen and Liposky sold after Cox's "management is unified" comments, do you think they were not privy to the BOD procedings re the ongoing negiotiations?
Jesse, I concur. Dew has pointed out that some (older) data already collected from the phase III post CABG study might still be acceptable to FDA. This would certainly accelerate evaluation in this indication. If I were a US potential partner would try to get to market ASAP, rather than duplicate risk of unsuccessful phase II DIC data were it to occur. Since DIC indication already under evaluation in Europe via LEO why follow a parallel track in the US? Once the phase II LEO data is evaluable than developement decisions re DIC could be made with perhaps less risk. The post CABG data was never an issue of efficacy but rather design and execution, as far as we know. To OldBerkley, don't sell, who will provide those great laughs for us? Just "wishing and hoping and hoping and waiting" How about the four other monoclonals under developemnt? bp
Re tomorrow: At least we know the income posted will be bang up with at least 15 million that Dr. Cox mentioned during one of the last calls that I think he said would be posted this quater. I think I have that right. Maybe the number will be higher. This kind of income would go a long way to offset our losses and reassure investors and potential partner. Am predicting the "few week" interval ends tomorrow with an announcement. If it doesn't I would interpret it positively as that wiley fox Cox is probably holding out for a better deal to finally recognize his few remaining "loyal investors", Lets see, that would be Dew, Flo, Louis, Rusty, Jessie, and me (Oh, and of course Henri and the kind Europeans as well). Plus a few others. Here's hoping! Go goats!!! bp
Dew Congratulations on your very fine call on MNTA. I still like my idea about Genz. Is that shot glass still around? If its Genz can I have it? Although Crou thinks the partnership will follow the general meeting, this seems unlikely to me. The overall "feel" of the market is much better and I think good news could cause a major reaction. Regards, bp
He knows. Have a position in Geron also and following with interest the stem cell therapies and the telOmere inhibitor GRN 163L which may have particular effect in multiple myeloma.
Musings on partnership: This has probably been rehashed before BUT--It seems that Genzyme has the most to gain and therefore is the most likely partner: They own what 4 million shares? (Dew correct me if I am wrong) so any signification infusion of cash increases the value of shares already held by Genzyme. If they put in 50 million (or just made a line of credit available for that matter) and the stock rose to 5, make an instant 40% back on their investment. They are in line for a portion of future profits from Atryn as part of their prior agreement with GTC so are motivated to see success. They have the right sales force. They have a history with Gtc and compatible future piplines. Dick Scotland came from Genzyme. Their profits are up and they have cash. Anything else to add?? (While we are waiting...) Regards to all, (Flo, you are not chopped liver but a carefully crafted blinz) bp
Louis, Dew, Flo, Jesse, fellow sports fans. We are not here for the buy out. We are here because this company has stayed alive for 10 (?) or so years and has great promise and "resiliancy". I have been in since the beginning up to heaven and down to hell. There will be a partner, there will be (positive) phase II DIC results. There will be funding of operations, there will be sales and there will be milestones, there will be products in the clinic for testing next year. There will be gold. Please Geoff. bp
Dew, Thanks for responding. This would means six to eight new transgenically produced products in two years! This seems optomistic to me but hey, why not. What candidates do you think? I personally think the MM-093 RA production should really amount to something for a large phase III trial. Regards, bp
keitern, I do not worry about profitability. Just the ability to have enough resources to continue developement. So far, and of course we all hope this changes soon, it just ain't there. And if it is there maybe someone can help me see it.
Not only completed but continues as an open label study which implies good tolerance and patient motivation to continue taking the drug. Flo, When can we expect the results to be presented or published? If positive the demand for more drug will help our bottom line as a phase III trial will need lots of product. bp
You are correct re milestone to LEO, I was working from memory (not as good as it once was). I also agree that Atryn will probably have many applications and could achieve "holy grail" status. The question is will we reap the benefits or will we need to be taken over to survive. I am just trying to get at how (speculations welcome) we can survive the year with so little money in the bank and not enough as yet on the way in to offset. There is a story perhaps apocrophal, re FedEx that at an early time in the companies history, payroll could not be met and a trip by the CEO to Las Vegas was helpful in bringing home the bacon. I am just trying to get at how Dr. Cox might pull the rabbit out of the hat to keep us independent and thriving. It would seem we might need two more years at 28 million a year which we do not have and may not get. With so much promise and so much hard work by those 150 employees, recognition, reward, and maintainance of independence is deserved. What possible events could bring it off? bp
Dew, A couple of thought while I await your usual trenchant financial analysis of our current situation. I have reviewed your RMF postings on our current finances and also your sanguine sense that insolvency is unlikely. From this our projected sources of income could include: 1. Partnership(s), single digit millions. 2. Milestone from Leo on US Atryn approval, not huge 3. Continued but "small" income from Merrimack and Pharmathene. 4. Possible partnership for CD 130 and A1AT again probably single digit millions. So what keeps us alive? I think the short term strategy is to limp through the year until phase II DIC data available which would add gladness (paging a Japanese partnership...)or doom and have a profound physhological effect on the stock and ability to raise financing. This seems to be the pivotal event of the upcoming months. Would a data safety and monitoring board ever stop a phase II study if conclusive data were positive before the study were completed? I can't help but feel we are racing against time with such wonderful potential and so little recognition. On this I agree with Dr. Cox in his unprepared remarks. While it is true we may be in the clinic with some of the anticoagulation factors in 2009, the studies are partially funded by GTCB. So seriously, from whence comes your sanguinity?? How will it be possible to do it? Regards, bp
Dew, Do you recall when the original study for AT III in heparin resistance in CAGB patients was done? Were results ever reported (I don't mean the recent plasma derived study, but the study using transgenic material), could any of this old data be used to support or at least decrease the number of patients required for a clinical study by a potential US partner in this indication and thus save time and headache in planning a future study? As I recall, it was hard to do the original study because the surgeons often deviated from the protocol for reasons I don't remember. A little bit off this topic, from a practical point of view, even if a new partnership gives us single digit millions up front and even if we have "pre booked" 15 million is income, where would you anticipate the remaining funds to insure solvency for the next year, say, would come from? I think I would like to buy more for all the reasons we both know well, but unless some new "surprise" partnership is announced its hard to see how we don't run out of money within the year. Please share your speculations. Regards, bp
Don't worry, be happy...you have plenty of company. bp
Thank you genisi and Dew. It seems everyone is working awfully hard to avoid using our (obvious, at least to some) technology! bp
Dew, I find this a very interesting post. Can you estimate how many units of collected human plasma would be required for a therapeutic dose? I assume out goat A1AT is a "biosimilar" not a bioequivalent. None the less one would think Kamada would be very interested in GTCBs technology as a way to provide pure, high quality product that did not require human plasma to produce. The common contact with the Alpha 1 Foundation is interesting and one would think they in particular would try to find a way to build a bridge between the two companies, to support GTCBs ongoing efforts. (Of course I thought the same thing about Bill Gates and Gtcb's dormant/read dead, malaria vaccine...) If the goat A1AT were a bioequivalent wouldn't that be a good thing (the planned half life issues I suppose would make that impossible)? My already shrunken 'nads are now the size of raisens but I would still buy more if I could. Regards to all, bp
Thanks, Dew.
Dew, Have been away with the kids this week (lots of mickey mouse and no goats). Can't quite get my arms around the LFB conversion of preferred to common stock. Why would they do that and what just it mean and what does it auger? Thanks in advance if you can clarify this for me. bp
Dew, If Dr. Cox purchase was to reassure stock holders, I think it has to some extent. I do not read a further delay in partnership. His purchase presumably was made on the basis of public knowlege. Knowing there is a partner and partnership is close would not prevent a buy since this is public knowlege. I wonder if the "who" however would be considered material to the purchase or not. Anyway I am glad he did it and think he was motivated by the outcry from his shareholders when the other insider shares were sold, especially after his pointed comments about the "united" management. He did it to reassure us. I'll bet the partnership announcement is not delayed. bp
And if you are you can borrow one of my Depends.
By the way Dew, without getting maudlin, you have, in a way held us together and kept us focused, Thanks.
Please answer soon, I am running out of "Depends" and I need to know if I should buy another box. bp
Dew, This is quite good news don't you think? Despite the blood in the streets so to speak we have a study which CONTINUES after initial enrollment in an open label fashion. The take away is #1. Not enough side effects to stop the study #2. Enough efficacy that patients are willing to continue in the open label arm. #3. Continued demand for product from our goats. I therefore think we will hear more about Merrimack and they will continue to provide at least some income to GTCB from purchase of MM-093. Flo, you have some contacts at Merrimack, do you think this is reasonable? I think I am ready to buy more but will wait for comments from others. Regards, bp
OK, OK. But I still think they could be the potential partner. Henri is so tough it might explain the hold up. Who knows the history and personell of the company better? bp
Genzyme has done it before with Genzyme tissue repair and GZMO. A little different because of tracking company status which we don't exactly have. In theory Genz as a large corporate owner of GTCB stock could be forcing downward pressure on the stock by selling now to perhaps get a better deal for atryn or take over. Dew?
The prestige of our partner who ever it might be will be important in moving the stock, reverse split or no. If it is a big pharma we will move if it a Leo equivalent (after all most of us never heard of them before GTCB partnership) e.g. a smaller, privately held company, than I think there will be little effect. bp
How about this. General Council needs $ for taxes. He and all insiders know they can't buy at these prices because of impending agreement and insider rules. He will not be penalized for selling under the regs because inside info indicates upside only. He could only be penalized for buying as could they all. If true (needs Backgammon champion evaluation), this would mean agreement will come after April 15th otherwise he would wait. Well, we all want to rationalize what looks like a bad situation. Regards to all, Anyone out there still buying? bp
From our company's web site.
It is against GTC Biotherapeutics, Inc. (“GTC”) policy for any person associated with GTC
to:
• Buy or sell GTC common stock or other securities (including contracts conveying
the right to buy shares (call options) or to sell shares (put options)) when you know
of material non-public information about GTC (“insider trading”).
• Disclose any material non-public information (also referred to as “inside
information”) relating to GTC to anyone outside GTC unless authorized to do so by
this Policy.
It is also a criminal offense to buy or sell our securities when you know of material non-
public information about GTC or to disclose our material non-public information to
anyone else if it is reasonably foreseeable that the person will trade in GTC securities based
on the information conveyed.
Violation of insider trading laws, rules and regulations, including this policy, will result in
severe disciplinary action by GTC, up to and including dismissal. You may also be subject
to legal penalties including fines and imprisonment.
He did say entire, I'm sure he said entire, he did say entire didn't he?
No doubt you are right, but new techniques are developed according to need. The tiny lymphatics of the foot lead to larger ones someplace that maybe could be defined and accessed. We are after all, especially after today's antics by our general council clutching at the proverbial straw. Regards, bp
Unfortunately he doesn't think the terms of the contract will move the stock price. Nausea anyone? Even if he needed it for taxes, April 15th is a month away. So lets define "few" as opposed to "several". I guess it all depends what "is" is a la Bill. As my grandfather would say--Oy. bp
I would never belittle what a patient goes through for a study such as this. But a dreadfully ill septic patient goes though the equivalent of this and much more so a slow infusion through a toe lymphatic, if it stops the DIC (so far nothing else does and maybe IV infusions will need supplemental access to lymphatics for better effect (who knows??). Who ever though we'd be sticking needles where we do (transcutaneous bx, fine needle aspirates, transseptal punctures etc, etc!) We may need to do what ever it takes, unattractive as it seems to us in our hopefully healthy states. bp
I'll bet our goats can outrun a Chinese hamster (ovary) anytime...bp
Dew, true enough but I just wondered whether their platform might also be adapted to such or if our goats might be superior regardless. One hopes. Regards, bp
MTB, #11 blades I think are small and pointy. Not too good for opening chests. Maybe a #10 would be better. Anyway both plenty sharp. When I was a medical intern, a star surgical intern opened his first chest for internal cardiac massage right across his mentors fingers. Blood filled the glove and the surgical resident was out of work for a while but returned completely intact and forgave his zealous intern who was really excellent by the way, just excited. Re the thoracic duct, I was just musing. What really would give access directly to the venous system easily and safely would be infusion into the lymphatics say in the foot the way a lymphangiogram is perfomred. No risk of bleeding there and very superficial skin access could be considered. Too far out?? What say you Jesse? Regards, bp
Re ADCC and Crucel, any ideas? bp
Dew, Have we been leap frogged? bp
Dew, unlike the usual defense industry board, I don't see any retired generals or military men or women. Other than a business relationship, I would think there should be a classified and clandistine relationship with DOD with programs such as these. If we could find that thread GTCB might be viewed as a government backed security in a sense. Too far out?? bp
While looking for central venous access to do pacemaker implants, I have found the thoracic duct, there would certainly be ways to infuse Atryn into the lymphatics. bp