GC - "We will now focus on completing the enrollme
Post# of 30028
Posted On: 08/07/2014 10:18:04 PM
GC - "We will now focus on completing the enrollment for LP-002 protocol and continuing preparations for commercial launch under CLIA"
GC - "When the Company became aware that 3 of the 4 sites had not completed their full enrollment, in part due to stringency in the Alzheimer’s subject selection criteria..."
In truth, of the 3 out of 4 sites, we don't know how close to finished they are!
Truth is we don't know the following,
1) how close the other 3 sites are to completion.
2) how we found out that 3 of 4 were out of "compliance", was it from the IRB themselves, or did Dr. Kirby notice something that he felt wasn't on point & therefore recommended going forward with the one sites numbers and unblind them.
3) was it a small error per GC "in part due to stringency in the Alzheimer’s subject selection criteria" that 1 or 2 of those sites didn't follow PROTOCOL?
4) AMBS decided to un-blind only 1 site, so will the other 3 be unblinded, or will they keep blinded?
On the BS/Basher side, we may never get that study finished...
On the reality side, just how quickly will $AMBS submit and get approval from the IRB? A week? Two weeks? 8 days? 5 weeks?
Like the 1 site that "...became aware that one of the sites had exceeded its enrollment criteria as it was able to get through Institutional Review Board (IRB) approval well ahead of the other.."
Bottom line is, after all that was said, this is still the Companies thought;
We are well positioned to continue forward with our LymPro program and remain on track to achieve our corporate objectives by the end of 2.
I'm in. And if I have something to do the day they announce and have all been approved, I won't sweat it. Or any other PR/Announcement that may come over the next 1-6wks. I will add when I can and sleep well and do things until news hits.
GC - "When the Company became aware that 3 of the 4 sites had not completed their full enrollment, in part due to stringency in the Alzheimer’s subject selection criteria..."
In truth, of the 3 out of 4 sites, we don't know how close to finished they are!
Truth is we don't know the following,
1) how close the other 3 sites are to completion.
2) how we found out that 3 of 4 were out of "compliance", was it from the IRB themselves, or did Dr. Kirby notice something that he felt wasn't on point & therefore recommended going forward with the one sites numbers and unblind them.
3) was it a small error per GC "in part due to stringency in the Alzheimer’s subject selection criteria" that 1 or 2 of those sites didn't follow PROTOCOL?
4) AMBS decided to un-blind only 1 site, so will the other 3 be unblinded, or will they keep blinded?
On the BS/Basher side, we may never get that study finished...
On the reality side, just how quickly will $AMBS submit and get approval from the IRB? A week? Two weeks? 8 days? 5 weeks?
Like the 1 site that "...became aware that one of the sites had exceeded its enrollment criteria as it was able to get through Institutional Review Board (IRB) approval well ahead of the other.."
Bottom line is, after all that was said, this is still the Companies thought;
We are well positioned to continue forward with our LymPro program and remain on track to achieve our corporate objectives by the end of 2.
I'm in. And if I have something to do the day they announce and have all been approved, I won't sweat it. Or any other PR/Announcement that may come over the next 1-6wks. I will add when I can and sleep well and do things until news hits.
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