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Pre_Clinical

08/15/07 9:24 AM

#4647 RE: vinmantoo #4644

There are many similarities. Yes tissue cells are in a more controlled environment but there are still issues, and I was referring in part to the idea that any DNA or RNA would somehow be a problem in isolating protein from milk as opposed to tissue culture cells, which is not he case.

Second, you really are exaggerating when you say god knows what pathogens. The goats are not roaming around on a farm mixing with other animals in the wild, but rather they are in a very controlled environment. You are far more at risk from humans by mixing in large crowd or confined space, say a sporting event, party, subway or airline. Sending your child to school or daycare exposes you to a hell of a lot of dangerous pathogens.

Third, if you are worried about goat proteins contaminating rATIII, then you should also worry to some extent that hamster proteins will contaminate CHO cells derived proteins.

I do understand that the general uninformed public may have issues, but that will be overcome with time. Especially if the DIC indication comes through. Nobody is going to worry about goats milk derived proteins when you are facing a 50% mortality rate unless you take rATIII.

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To your first point, the FDA has approved CHO cells as an expression system, hence it's validated and the technology/process development has been worked out. It's a known entity. Many, many approved biologics are expressed in this format, and many more are in the clinic. Once a master cell bank is obtained, the degree of product heterogeneity in this process is neglible. Let me break it down for you, to the FDA, heterogeneity in a manufacturing process is bad, homogeneity is good. In regards to DNA or viral contamination, the bottom line is that the FDA is convinced that it's not a problem for CHO cells. The verdict is still out on GTCB's expression format.

To the 2nd point, I still submit that there is a far, far, far greater concern about heterogeneity and contamination when dealing with a herd of animals than a fermentation culture of CHO cells. Mother Nature is an extremely powerful force and she has ways of wreaking havoc in a manner which you never imagined. However, as I stated before, I believe that GTCB's scientists have overcome this risk, and in this case, it's a good thing, because this risk is the single most important reason that we all have been able to purchase this stock at a very nice discount.


To your 3rd point, we all hope that the DIC indication (in your words) "comes through". The market certainly is huge and we would all make at least 10X on our investment. The problem with sepsis is that basically the body is in full blown nuclear meltdown. It's a very risky indication where many compounds have failed. There are a lot of unknowns.

I have been in this game for a while and it's my personal philosophy that companies with interesting new technologies should not compound their risk by applying their technology to difficult or intractable targets. Having said that, the DIC sepsis story is tantalizing. Gotta run...