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Re: zoomboom post# 80241

Wednesday, 08/07/2013 7:22:00 PM

Wednesday, August 07, 2013 7:22:00 PM

Post# of 130508

AMBS. Verified. Now soon in process of Validation.



Seems to be a difference of opinion on both validation and time frames.

I responded to the claim that LymPro analytical performance gets validated (any day now)...."

There is no confirmation in Geralds' letter that that has occurred, nor is there any mention of a time frame for data release before 2014:

"..data available in the first half of 2014."

If the results from the BD assay were available, is it likely that Gerald wouldn't have PR'd them?


"Once LymPro analytical performance gets validated (any day now)...."
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"....the Company expects to initiate a pivotal diagnostic accuracy study (Phase 2) at the same independent laboratory to generate sufficient data to validate the clinical performance (sensitivity / specificity) that would support a CLIA launch, with data available in the first half of 2014. "In the next 6 months, we expect to be initiating a pivotal clinical study to support the commercial launch of LymPro as a CLIA-waived Laboratory-Developed Test ("LDT").