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marzan

09/19/19 12:37 PM

#215129 RE: Biobillionair #215127

Thanks BB for nailing JT for an answer but neither he nor FDA could come up with yet it seems. So all FDA has to figure out is that MRC is a fake con artist. Once they determine which they might have already (the proof is their new guidance just released a few days ago on citizen petitions) that MRC is con artist as he himself declared he is a big time short, I am sure they release sNDA decision by 9/28 - very possible.

ziploc_1

09/19/19 12:48 PM

#215133 RE: Biobillionair #215127

BB...IMO The FDA decided on the Adcom because the discussion of what Trigs or Statins, if any, should be part of the label...was already becoming a hot topic...Mentioning, at this time, their rational for their decision to have an Adcom would only have added fuel to the fire...and it would be better to leave it for discussion at the Adcom...IMO the MRC petition had nothing to do with the FDA Adcom decision.

Mellowmood77

09/19/19 3:43 PM

#215188 RE: Biobillionair #215127

Thank you BIO, you just did this board a huge service and let me explain why...

Your conversation with JT is very interesting, so is the new guidance for CP’s.

It proves MRC is wrong yet again, claiming that Amarin is withholding material information from shareholders and in breach of SEC violations. Now we know Amarin was in fact not solicited with information by the FDA. This is a big deal.

Now, whether MRC GENUINELY believed Amarin was solicited for information, OR he was just trying to instill fear into investors, does not matter anymore. The truth has been revealed and has crippled MRC.

With this knowledge you’ve provided along with the FDA’s new guidance on CP’s, I believe the FDA, as you stated, was put in bad spot. The CP’s MRC posted was extremely profound and I believe by mandate, the FDA could not ignore them (which is why they issued new guidance).

MRC is definitely working with someone. This is not the act of a lone bandit. I said before many times that I believe MRC is either in bed with hedge funds that want in at a cheaper price or BP who want’s to either derail Vascepa or own it at cheaper valuations.

Someone knew how to game the FDA and they did just that, GAMED them. Didn’t somewhere in the new guidance say something about no longer being allowed to purposely file a LATE CP for the sole purpose of delaying PDUFA? Didn’t RAF say he had a source that the FDA actually felt bad for the late ADCOM and made this apparent to JT? The CP causing a late ADCOM makes the most sense now with this new information.

Remember in my earlier posts I was talking about shakeouts? Just look at what the stock has done in the past 2 months. All the shares that were traded in the 13’s, 14’s, 15’s have quickly been ABSORBED. No 13G’s have been filed by BB which means they did not sell a substantial amount and maybe even bought more. Other institutions have been adding. Look at ORBIMED ADVISORS. They used to own FORTY percent of AMRN before they completely cashed out... they have started to make a position AGAIN.

This has the potential to be a blockbuster drug of ages. It will shake out weak hands AS MUCH AS IT CAN by lowering SP until the only way to get rid of the retail investors is to start RAISING the price.

Will another shakeout happen? Probably. MRC isn’t done as he’s creating another 50+ page report for the ADCOM comment. Will it be as big as the ADCOM announcement? Doubt it.

One thing is for certain. JT telling BIO the reason for PDUFA wasn’t due to solicited information causing an amendment to the sNDA is very good news. Thanks Bio for posting.