Hard to say of course. But I feel, based on Pr inf
Post# of 5066
Posted On: 10/10/2014 8:02:10 PM
Hard to say of course. But I feel, based on Pr information, the testing hasalready been done .
As far as information transmitted to FDA, i feel like they are more well equipped for successful discourse as they have and are in communication over HemaX (as in PR). However, IRBs and other groups analyzing sections of the IND for Dcell might be altogether different people, so perhaps this is not an idea that can be correlated with rapport and increased efficiency.
All-in-all, i say there will be an IND number (if not already) assigned very soon. I am confident the company has prepared and given all (and I would assume more than) needed information to the FDA. However, given the nature of this kind of therapy, i'll bet there will be questions. I'm also confident these concerns, if presented to the company, will be adequately addressed.
Forgot to mention this science (gene silencing) is being licensed out by Benitec and used by others. So perhaps many issues that would have been raised, have already surfaced elsewhere, giving BMSN/RGBP some headway in the matter in accordance to FDA.
I am excited to see how long it is before we hear about DcellVax again, and HemaXellrate I, for that matter. It is all so so close when you consider the journey. Don't forget about HemaXellerate II ! haven't heard buz about that in a while.
Unfortunately, until super funding is in play, this will be manipulated by some big players. They are loading and keeping it down, a very tragic display of confidence in the stock, and hard for a company, trying to raise funds, to go through. I hope to see a continued rise into the anticipation of open NDAs and approval PRs into the end of the year.
As far as information transmitted to FDA, i feel like they are more well equipped for successful discourse as they have and are in communication over HemaX (as in PR). However, IRBs and other groups analyzing sections of the IND for Dcell might be altogether different people, so perhaps this is not an idea that can be correlated with rapport and increased efficiency.
All-in-all, i say there will be an IND number (if not already) assigned very soon. I am confident the company has prepared and given all (and I would assume more than) needed information to the FDA. However, given the nature of this kind of therapy, i'll bet there will be questions. I'm also confident these concerns, if presented to the company, will be adequately addressed.
Forgot to mention this science (gene silencing) is being licensed out by Benitec and used by others. So perhaps many issues that would have been raised, have already surfaced elsewhere, giving BMSN/RGBP some headway in the matter in accordance to FDA.
I am excited to see how long it is before we hear about DcellVax again, and HemaXellrate I, for that matter. It is all so so close when you consider the journey. Don't forget about HemaXellerate II ! haven't heard buz about that in a while.
Unfortunately, until super funding is in play, this will be manipulated by some big players. They are loading and keeping it down, a very tragic display of confidence in the stock, and hard for a company, trying to raise funds, to go through. I hope to see a continued rise into the anticipation of open NDAs and approval PRs into the end of the year.
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