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randychub

03/02/04 2:11 PM

#31 RE: randychub #30

A couple of things I have found out since my last post.

If to much of the antibody is given it will drift down to other sites. This should not be a problem.

old sales estimates - "RIGScan uses a tumor-specific targeting agent and a medical device to ensure that surgeons don't miss any part of a cancerous tumor, and is expected to generate $280 million in sales 3 years after approval (1997)

Neop has not yet collected all the data from the previously run crc trials. They collected a small portion and because of the results of the data they collected they want to meet with the FDA again. Neop intends to find out if they get a complete collection of data and the data is positive, will that data be enough to complete the BLA previously submitted.


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DewDiligence

03/21/04 1:03 AM

#65 RE: randychub #30

>> I take it the thyroid function mentioned in the bio conf was due to current markers hurting the thyroid gland. Any ideas how bad of a problem this is? <<

In #msg-2648091, there is mention of protecting the thyroid from the RIGS antbody. See the second paragraph in the main body of the report:

“Saturated solution of potassium iodide (10 drops by mouth twice daily) is prescribed two days before injection of the radiolabeled MAb and continued for three weeks to minimize uptake of 125I by the thyroid.”