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dr_lowenstein

07/27/16 3:43 PM

#218255 RE: WeeZuhl #218251

Well gee I guess that means two things: 1.fda does not have access to the medical literature or 2. Fda does not have any competent medical doctors on staff. Should we suggest that fad read the medical findings published in the alternate literature universe?

Gman24

07/27/16 3:49 PM

#218258 RE: WeeZuhl #218251

I totally agree.. Nice post WeeZuhl... This should be a sticky. I don't care how many you have to remove. Great DD

Couch

07/27/16 3:51 PM

#218259 RE: WeeZuhl #218251

TIME for a NEW STICKY NOTE

no2koolaid

07/27/16 3:58 PM

#218261 RE: WeeZuhl #218251

Excellent post, thanks for weighing in with your medical perspective...

I am a big proponent of evidence based decision-making and speak to that point often in front of large groups. And, it is from that understanding that I concur with your assessment about the FDA and their future decision on Elite's second submittal of SequestOx...

RLSJ84

07/27/16 4:03 PM

#218263 RE: WeeZuhl #218251

So just like that you now believe this is BS?

After calling it zombie sequestox?


Don'tDrinkTheKoolAid

07/27/16 4:09 PM

#218267 RE: WeeZuhl #218251

NO ADCOM + Expedited review=APPROVAL just don't drink 1 glass of wine for that formula get a few gallons to go with it. You'll need it next CC.

mrwrn2010

07/27/16 4:14 PM

#218271 RE: WeeZuhl #218251

Wow awesome post man. You should send this to Dianne. I bet Eugene would love this sh*t.

warrentt

07/27/16 6:53 PM

#218356 RE: WeeZuhl #218251

In this case, it seem to be more beneficial to ELTP if they get an ADCOM meeting.

Since only the medical expert would understand what are the true risk of delay Tmax when taken with fatty meal.

As a normal consumer/patient, I would prefer drug without the requirement to be taken with food. If I'm in pain, i'm gonna take that pain reliever.

Especially if this is immediate relief purpose, why do I need to wait to take with some food. It is just some common sense. In my opinion, FDA just want to cover their ass in any way possible given the current scrutiny on opoid abuse.

COO2002COO

07/27/16 11:23 PM

#218410 RE: WeeZuhl #218251

This is just a highly valuable assessment for us to understand better the current situation ELTP with the FDA, from a medical professional's perspective.

Thanks WeeZuhl.