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To: gao seng who wrote (3417)5/24/1999 1:24:00 PM
From: kenita  Respond to of 4122
 
So ….amend and resubmit it.

IDSI may obtain further delays by this:

"The Company intends to perform studies at four hospitals each of, which will follow the IDE protocol for 275 volunteers to acquire effectiveness data on 1,100 women. Of these, 400 will be selected for actual submission. The reason for the plan to scan 1,100 women instead of only 400 is that volunteers in these kinds of programs for various reasons may withdraw from the study, not have a histological confirmation of their respective condition, for example a woman dies before her surgery, or other reason.

What can IDSI gain here… 3 MORE years perhaps more?



To: gao seng who wrote (3417)5/24/1999 1:39:00 PM
From: Labrador  Read Replies (3) | Respond to of 4122
 
Come on, do you really think that posters on these boards really influence a change in the agreement on trials?