Time will tell. Why didn't they say, "We respon
Post# of 5066
Posted On: 05/15/2014 2:05:47 PM
Time will tell.
Why didn't they say, "We responded to the FDA request of further clarification on May 9th" or "We provided further clarification on data of animal studies with our new IND submission on May 9th" or even, "Requested clarification was provided on May 9th."
Instead they say that they hope clarification will be resolved in a "timely manner". Well, they talked about being on track for normal FDA process last year in March after the initial IND, so "timely manner" has basically, no time frame.
Citing that others want the process to move forward to me indicates that the FDA issued some type of resistance or red flag on what was submitted. A petition of other scientists isn't going to produce FDA approval.
I'm invested, but whereas reading the blogs had me previously always expecting success around the corner if not sooner, I am now more calm and resigned to the fact that this process takes more time than people give thought to in many cases and this is not yet a slam dunk or the PR would have expressed that in my opinion.
I'm not going anywhere, my money's already tied up and I need this to more than double from current prices to break even. Just trying to get a realistic outlook and expectation so as not to be constantly disappointed in false expectations.
Why didn't they say, "We responded to the FDA request of further clarification on May 9th" or "We provided further clarification on data of animal studies with our new IND submission on May 9th" or even, "Requested clarification was provided on May 9th."
Instead they say that they hope clarification will be resolved in a "timely manner". Well, they talked about being on track for normal FDA process last year in March after the initial IND, so "timely manner" has basically, no time frame.
Citing that others want the process to move forward to me indicates that the FDA issued some type of resistance or red flag on what was submitted. A petition of other scientists isn't going to produce FDA approval.
I'm invested, but whereas reading the blogs had me previously always expecting success around the corner if not sooner, I am now more calm and resigned to the fact that this process takes more time than people give thought to in many cases and this is not yet a slam dunk or the PR would have expressed that in my opinion.
I'm not going anywhere, my money's already tied up and I need this to more than double from current prices to break even. Just trying to get a realistic outlook and expectation so as not to be constantly disappointed in false expectations.
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