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@TripleGateCaptl Avatar @TripleGateCaptl BoredCorso

Investors are reacting to the recent PDUFA delay of $SRRK, which was caused by an OAI (Official Action Indicated) recommendation due to issues at the Catalent plant. Management's comments on the issue have been widely disputed as inaccurate, with some investors expressing concerns that the facility's problems are not easily resolvable. The delay is expected to result in a likely Complete Response Letter (CRL) for $SRRK.

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Social category influence stocks finance

Social topic influence $regn #5, $nvo #78, $srrk #2, $ctlt #1, all the, $alxn, bla, approved, up the, $nvos

Top assets mentioned Regeneron Pharmaceuticals Inc (REGN) Novo-Nordisk (NVO) Scholar Rock Holding Corporation Common Stock (SRRK) Catalent Inc (CTLT)

Top Social Posts #

Top posts by engagements in the last XX hours

"FDA placed Catalent Indiana under OAI on October X 2025 Worst case scenario for $REGN and $SRRK. Need new CDMOs. $REGN should issue PR within XX hours; NO Eylea HD approvals in 2025. $SRRK most likely launch 2H 2027"
X Link @TripleGateCaptl 2025-10-12T15:12Z XXX followers, 23.3K engagements

"@Biotech2k1 Hi. What makes you think issues will be fixed quickly What will $NVO do in the next few months they couldnt do in the first seven Or what $CTLT couldnt do in X years"
X Link @TripleGateCaptl 2025-09-19T14:33Z XXX followers, XXX engagements

"@blankspacenom At $ALXN they hired Lonza for their BLA. Thats one of the highest quality CDMOs in the world. This time around they picked the opposite extreme"
X Link @TripleGateCaptl 2025-09-15T20:51Z XXX followers, XXX engagements

"$REGN Hail Marry: 1) I think $REGN has submitted a backup filler in their Libtayo BLA and they are hoping for a favor from the oncology division for the FDA to consider that a major amendment 2) Bloomington absolutely impossible to be resolved 3) I think approval on 10/11 impossible even though $REGN is confident"
X Link @TripleGateCaptl 2025-10-06T19:00Z XXX followers, 6459 engagements

"$REGN implication from Catalent OAI: Unlike with Libtayo $REGN does NOT have an approved backup filler. Therefore they should receive a 6-month PDUFA upon re-filing post CRL. If they manufactured stability batches TODAY with the alternate CDMO they have been working with then it should be about a year delay for Eylea HD PFS. If they havent manufactured those yet then it should take longer"
X Link @TripleGateCaptl 2025-10-13T09:44Z XXX followers, 3974 engagements

"Unfortunately old mgmt screwed up the application by picking a huge CDMO with terrible regulatory history for a low volume product. New mgmt I think decided to cover it up and take a chance on $NVOs ability to muscle the FDA. They lost and now they are between a rock and a hard place. Pun intended"
X Link @TripleGateCaptl 2025-10-12T23:56Z XXX followers, XXX engagements

"I disagree. This is great for $NVO. They want all the capacity to themselves. I think they would be happy if all the customers left. The FDA bent over backwards to allow Wegovy from this plant. OAI doesnt impact current products. Now if they screw things up which they may and the FDA escalates then they may have problems"
X Link @TripleGateCaptl 2025-10-13T19:22Z XXX followers, XXX engagements

"$SRRK During my prior life at SAC I used to say that sell-side should be abolished and companies should write their own research. Investors would find out quickly whos reliable and whos not. Things only got worse. You can literally say anything to analysts today and theyll faithfully repeat it without a pinch of curiosity due diligence or even common sense. 1) what kind of robust responses could $NVO have possibly submitted XX days after the inspection How could they possibly know what corrective actions will be needed to resolve thousands of deviations when they havent even conducted any of"
X Link @TripleGateCaptl 2025-10-13T21:16Z XXX followers, 3999 engagements

"Fun fact FDA contacted me today asking to delete the version of the Catalent Form XXX which identifies $REGN products by name and only use this new version which doesnt:"
X Link @TripleGateCaptl 2025-10-06T19:13Z XXX followers, 2729 engagements

"@smiuffy Shows these people have no idea how to request documents and no clue what they are asking for. Its crazy"
X Link @TripleGateCaptl 2025-10-13T04:54Z XXX followers, XXX engagements

"@KavodCapital @BiotechMd @srqstockpicker What do you mean if its true But to your point I showed in my prior article tha $NVO kept all the executives but a junior person whom the inherited from the Nov 2023 inspection. Plus the $CTLT CEO"
X Link @TripleGateCaptl 2025-10-12T20:07Z XXX followers, XXX engagements