Replies to post #20852 on Grapefruit USA Inc (GPFT)

[pendragon8062]

Why is it so hard to consider that part of the onus for being unable to open the images is on the FDA?

In my personal experience working with a variety of government agencies from a consulting perspective, the following scenarios have happened:

1. Agency asked for document in X format, we provide in X and they say, "sorry we changed to Y format after our last meeting, please resubmit.

2. Agency asked for document in X format, we provide it in X and they say "Sorry, we need it in version X from 10 years ago. Please resubmit."

3. Agency asked for document and said "Send it in one of the following formats: x,y,z. We send it in Y and they say "Oops, we made a mistake, we can't open Y, please send it in X or Z".

4. Agency asked for document in Y, we sent it in Y, and they say "Sorry, our configuration of Y prevents us from opening files larger the B size in it. Could you resend it in G?

5. Individual from agency said "Give it to me in X." Three weeks go by, another individual says "Bob's gone now, I need it in Z."

Now in our case, these were predominantly electronic submissions so the resubmitall process is fairly quick, but it tooks days, sometimes weeks before we'd be notified by the agency there was a problem and often times even though there could be a quick workaround, the agency requested it brand new from us. Even when we were extremely proactive by confirming format just before submission, we still got caught by the above things because the decision making process in govt. is horribly slow. Our contact didn't know that format X was phased out, so he thought it was peachy and told us to use X until his superior told him.

When I look at this, I see run-of-the mill govt. IT systems and procedures.

[IMGGorBust]

I'll do my best to set address your concern.

I deal with government agencies all the time. It is my business. In particular, I produce large volumes of electronic documents to government agencies in response to subpoenas and document and information requests. We have problems with one or two files we produce in these mega productions just about 100% of the time. It's not a matter of sending the agency the wrong file format, or a file type they don't support, or not following some agency procedure. Most ofetn it's a matter of technology not being perfect and in particular, federal technology and tech support being laughable. Files get corrupted, on both ends. We test our production files before we send them, but for some reason, somewhere along the way, a small percentage of the files become unreadable on the agency's end. Perhaps the agency did something to corrupt the file. Perhaps they've done something to corrupt the computer on which they're reviewing the file. Perhaps the vendor we use to make copies of the electronic files fouls something up. The fact is, it happens all the time, and it's no big deal. The agency points out which specific files it couldn't open, and we recreate those files and resend them.

Note that Dean did not say the agency could not open the entire application. Note that he didn't even say they could open all of the images. He just said there were a couple that they had trouble opening. Do you really think he used different file types for some of the images? No. This is such a typical occurence. Everyone is way off base when they say Dean made some huge blunder and sent the wrong file type. I am certain this is not a file type problem, but rather, a file or two, that for whatever reason there was trouble opening. It is so common and so easy to address.

I cannot believe that there is a single person on this Board who can say that they have never had an issue sharing electronic files. That some electronic file that a recipient from you said they couldn't open, even though it was a basic file type that they surely had on their computer, or that yourself could not open even though it was a file type that your computer supported. It happens all the time. Stop trying to read the most devious meanings into something that happens all the time.

I hope that addressed your concern.