Gener

Dondadda

[Gener @Gener63015339]

@SheffStation They signed a contract saying Week 8 was the measure of success, and they missed it. A 351(a) has to stand on its own adequate and well controlled investigations. The sponsor has not produced those.

[Gener @Gener63015339]

@SheffStation 3. The FDA cannot "Refuse to File" (RTF) a resubmission just because the data is weak. If the application is "complete," (ie, not missing any sections) they must file it. The logic is simple: It's a 351a that failed the SPA primary endpoint (Week 8).

[Gener @Gener63015339]

@SheffStation 2. The FDA "encourages" Type A meetings for virtually every CRL. It is the standard operating procedure for dispute resolution. It is not a signal of intent to approve; it is a signal that the FDA is following protocol.

[Gener @Gener63015339]

@SheffStation it means the file is effectively empty of new evidence, so they don’t need 6 months to review it. It confirms OTLK is trying to re-argue the old failed data rather than fixing the problem with a new trial.

[Gener @Gener63015339]

@SheffStation here is the thesis. It’s not "bizarro world," it’s standard FDA procedure:
1. You are confusing "Priority Review" with "Class 1 Resubmission." Per FDA MAPP policy, Class 1 is mandatory if the sponsor submits no new clinical data. It doesn't mean the FDA likes the application;

[Gener @Gener63015339]

@Christian8C_ Go where? Im a bull, and Im disappointed in the stocks performance. It can't hold a gain or move pass .20c to save its life!!!

[Gener @Gener63015339]

@Christian8C_ Worst stock to ask for a green day. Beats me! This POS can never keep any gains.

[Gener @Gener63015339]

@dg_fit61882 No, it is t staying a $19 M company, but certainly a $19.5M company! This stock is pathetic. Can't keep any gains. Can't even get over .20c.

[Gener @Gener63015339]

@dg_fit61882 Yet stock can't even go pass .20c.

[Gener @Gener63015339]

@belowcashbuyer There is no damn good news here!

[Gener @Gener63015339]

@Loafyh @LTbioinvestor Exactly! Algorithm keep shorting the sector on every macro news- good or bad! This is the worse sector ever now!

[Gener @Gener63015339]

@LTbioinvestor Exactly! Worst performing sector ever since 2010. It use to be insulate from all these macro news! But the sh..t pit of all markets!

[Gener @Gener63015339]

@ApeNationsCo @Theperfectlap70 @ATLanalyst @fsajack Exactly. This company is deliberately trying to sabotage its stock price. I was in a company where every single time the stock price appreciated, they dropped a negative PR the same evening.

[Gener @Gener63015339]

@TraderJoe6 @forder_callum exactly! lying POS the are. All pumpers!

[Gener @Gener63015339]

@mjam2020 @forder_callum @TraderJoe6 Idiot, they didn't get any funds from this. It's a convertible

[Gener @Gener63015339]

@Opal_Chip Opal, I got converted over to Schwab from TD Ameritrade, and hate it so far. Which platform are to switching to? I need a good platform that is simple. Thanks

[Gener @Gener63015339]

@Biotrade_alert And then it went down to $1.88. This has to be the lamest piece of shit pdufa I ever seen and been in. This 💩 cannot, at no time keep any gains or close over $2 to save its life. It trade at or above $2 every single day but either closes red or under $2. POS

[Gener @Gener63015339]

$ckpt this ought to be the hardest fucking stock to close a day over $2. What a fucking turd.

[Gener @Gener63015339]

@Parabolicone @CsokaDan @MrJoeBartell @Dr_Jamaloodeen Shut the fuck up, idiot

[Gener @Gener63015339]

@MitchellReed09 @_joebaffoe @PowerballUSA @Biotech_SD @FierceBiotech @SquawkCNBC @IAmBiotech @MadMoneyOnCNBC @SeekingAlpha Yet, it’s trading like a lame dog!