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rosemountbomber

02/12/19 8:56 AM

#175775 RE: BaaBaa45 #175772

Wanted to chime in on this. The FDA has been sending out warning letters for a long long time. Not something new. On the FDA website they have warning letters archived back to 2005.

Biobillionair

02/12/19 9:03 AM

#175777 RE: BaaBaa45 #175772

Everyone!!! You should read the warning letter. Baa you are not exaggerating the significance of the movement the FDA has now taken.

On the webpage titled, “Omega 3 Benefits Stroke – Fish Oil Supplement May Help”:
Fish oil supplements have been shown to have anti-inflammatory effects in diseases such as cancer, asthma, rheumatoid arthritis, osteoporosis, dry eye disease, age-related macular degeneration, coronary heart disease and sepsis.”
“The use of fish oil supplements as a protective factor against stroke and other neurological diseases such as Alzheimer’s has been suggested.”



Above is enough of a warning for Amarin to submit Vascepa sNDA...

My best guess is February 14th 2019....Happy Valentines Day Amarin Longs!!!!

BB

jfmcrr

02/12/19 11:52 AM

#175812 RE: BaaBaa45 #175772

FDA letter. First of a wave? ITC victory imminent?





It seems like there are multiple issues being conflated.

Esterfid DS's are a drug and therefore illegal.

Fish oil has not been scientifically proven to be beneficial by Reduce It.

Fish oil has not been proven, cancer, propecia, AD, aftos, or glanders.

A broad campaign against 1st dangerous, then useless or mislabeled DS's.

north40000

02/12/19 2:17 PM

#175841 RE: BaaBaa45 #175772

There are ~ 15-17 such letters that were sent by FDA to their entities.