10-Q out and we now know nothing more than what we
Post# of 5066
Posted On: 08/13/2014 4:36:40 PM
10-Q out and we now know nothing more than what we did months ago.
This is depressing. 3 and a half months after "clarification needed" for HemaXellerate and we know absolutely nothing of its status and whether or not there is really any concrete hope for its future or not. 3 months and shareholders have not been given a plan, an insight to the problem or anything. It was back in Feb 2013 that HemaXellerate was submitted and then not that long after questions that BMSN considered a normal part of the FDA approval process needed to be answered. Here we are more than a year later and we know only that BMSN has approval for the manufacturing process (because it is not dependent on BMSN, but someone else) and FDA has worked out necessary protocol, but the main element, the safety of HemaXellerate I was questioned and 3 months later we are still in the dark.
So a year and a half after IND submission, "the normal FDA review process" is still ongoing according to Koos.
In light of this, dCellVax might be years away as well since the "news" we got was that some similar aspect to dCellVax worked in human cells, but if you read the PR, it was clear that it wasn't the exactly the same. When Koos releases a PR that sidesteps the obvious questions, it is never a good sign.
I am almost out of hope and patience. For those of you who have posted that Koos always keeps his promises and schedules, it is not even close to being believable, I'm sorry.
This is depressing. 3 and a half months after "clarification needed" for HemaXellerate and we know absolutely nothing of its status and whether or not there is really any concrete hope for its future or not. 3 months and shareholders have not been given a plan, an insight to the problem or anything. It was back in Feb 2013 that HemaXellerate was submitted and then not that long after questions that BMSN considered a normal part of the FDA approval process needed to be answered. Here we are more than a year later and we know only that BMSN has approval for the manufacturing process (because it is not dependent on BMSN, but someone else) and FDA has worked out necessary protocol, but the main element, the safety of HemaXellerate I was questioned and 3 months later we are still in the dark.
So a year and a half after IND submission, "the normal FDA review process" is still ongoing according to Koos.
In light of this, dCellVax might be years away as well since the "news" we got was that some similar aspect to dCellVax worked in human cells, but if you read the PR, it was clear that it wasn't the exactly the same. When Koos releases a PR that sidesteps the obvious questions, it is never a good sign.
I am almost out of hope and patience. For those of you who have posted that Koos always keeps his promises and schedules, it is not even close to being believable, I'm sorry.
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