Deputy, I agree in this sense; when reading it,
Post# of 30066
Posted On: 08/11/2014 7:38:22 PM
Re: Deputy_123 #3609
Deputy,
I agree in this sense; when reading it, ppl got their hopes up. Reading into it what "we" all hoped for.
This may be a bit repetitive for those who have read this before, but there is a bit more info now..
This is before last nights Blog...
"We will now focus on completing the enrollment for LP-002 protocol and continuing preparations for commercial launch under CLIA" - GC
Real questions to be asked would be:
When did the Company become 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...
Of the 3 out of 4 sites, How close to finished are they?
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?
3) was is 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 blinded still, or will they keep blinded?
for those who want to Bash, your argument would be we may never get that study finished...
On the reality side, just how quickly will $AMBS submit and get approval from the IRB? 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 site." - GC
Bottom line is after all that was said, this is still the Companies objective!
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.
And now with last nights blog;
The Company is currently completing the enrollment of its LP-002 clinical study, and based on the interim data will likely increase the number of subjects entered in the study in order to properly power certain key data aspects that were emerging in the interim data set and may add significant value to LymPro on a near-term basis. We are on track to announce full data sets for LymPro later this quarter.
Science is funny sometimes! Looking for A and instead not only do we find A, but B-G show up!
And, the IRB is "guiding" our move; in terms of what they want, are looking for and will except!
They already APPROVED 1 site. All we need to do is replicate that site. Sure, we could be years away from being able to do that.... But if one believes that, I would say walk away and just turn on the computer years from now. But that doesn't seem to be the case...
For me at least...
Facts are Facts and Opinions are just that....
I agree in this sense; when reading it, ppl got their hopes up. Reading into it what "we" all hoped for.
This may be a bit repetitive for those who have read this before, but there is a bit more info now..
This is before last nights Blog...
"We will now focus on completing the enrollment for LP-002 protocol and continuing preparations for commercial launch under CLIA" - GC
Real questions to be asked would be:
When did the Company become 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...
Of the 3 out of 4 sites, How close to finished are they?
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?
3) was is 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 blinded still, or will they keep blinded?
for those who want to Bash, your argument would be we may never get that study finished...
On the reality side, just how quickly will $AMBS submit and get approval from the IRB? 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 site." - GC
Bottom line is after all that was said, this is still the Companies objective!
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.
And now with last nights blog;
The Company is currently completing the enrollment of its LP-002 clinical study, and based on the interim data will likely increase the number of subjects entered in the study in order to properly power certain key data aspects that were emerging in the interim data set and may add significant value to LymPro on a near-term basis. We are on track to announce full data sets for LymPro later this quarter.
Science is funny sometimes! Looking for A and instead not only do we find A, but B-G show up!
And, the IRB is "guiding" our move; in terms of what they want, are looking for and will except!
They already APPROVED 1 site. All we need to do is replicate that site. Sure, we could be years away from being able to do that.... But if one believes that, I would say walk away and just turn on the computer years from now. But that doesn't seem to be the case...
For me at least...
Facts are Facts and Opinions are just that....
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