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[@TripleGateCaptl](/creator/twitter/TripleGateCaptl)
"Will $SRRK get approval during 2026"  
[X Link](https://x.com/TripleGateCaptl/status/1977257092777230504) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-12T06:16Z XXX followers, 1099 engagements


"$SRRK just issued a statement admitting they do not have any alternate CDMO in the works. It will be a LONG wait until they get approved from a new plant. Pun intended"  
[X Link](https://x.com/TripleGateCaptl/status/1977711699877576859) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T12:23Z XXX followers, 4545 engagements


"I genuinely cannot figure out if $SRRK mgmt has giant chutzpah to be telling investors such nonsense or they are actually this ignorant. EVERY SINGLE CRL issued by FDA followed a CDMO saying to their client that they are ready for inspection. Even in this case how many times they said they were confident in quick resolution and majority of observations have already been resolved and then an OAI comes. And for professionals to invest other peoples money on such information I think is gross negligence. Just have anyone look at ALL the FDA documents. Not possible to find anyone w half a brain to"  
[X Link](https://x.com/TripleGateCaptl/status/1977775696773632108) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T16:37Z XXX followers, 3426 engagements


"OMG. Who's dumber sell-side or $SRRK management This is outrageous. From one investment bank below. Under Option 1: if $SRRK re-filed during OAI then they would receive a 6-month PDUFA. If the plant is not ready in X months then they would get ANOTHER CRL. Who would be dumb enough to do that Either $SRRK hangs around and waits to refile until OAI is removed or Option 3: they just move to a clean facility and get approval 2H 2027. None of this is complicated. It doesn't require any guidance from the FDA. This is pure basics"  
[X Link](https://x.com/TripleGateCaptl/status/1977723284549472444) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T13:09Z XXX followers, 12.1K engagements


"@monaco_biotech Can you point to any comment I made about the stock or the valuation I didn't think so. I am exclusively talking about the realities of getting their product approved. No one has control over a stock price. But we can control what information we base our decisions on"  
[X Link](https://x.com/TripleGateCaptl/status/1977803997139644889) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T18:29Z XXX followers, XXX engagements


"@monaco_biotech Why are you reading my comments"  
[X Link](https://x.com/TripleGateCaptl/status/1977812463740731493) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T19:03Z 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](https://x.com/TripleGateCaptl/status/1977845948354277483) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T21:16Z XXX followers, 5048 engagements


"@MelvinRiskMgmt At least if all these banks at least had gotten a financing out of $SRRK for publishing all this hogwash I would understand the effort. But they are making fools of themselves for nothing. They are better conditioned than my dog"  
[X Link](https://x.com/TripleGateCaptl/status/1978643104920953263) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-16T02:04Z XXX followers, XXX 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](https://x.com/TripleGateCaptl/status/1977523876549496926) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-12T23:56Z 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](https://x.com/TripleGateCaptl/status/1967692845214822570) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-09-15T20:51Z XXX followers, XXX 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](https://x.com/TripleGateCaptl/status/1969047252346777727) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-09-19T14:33Z 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](https://x.com/TripleGateCaptl/status/1975275016666419460) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-06T19:00Z XXX followers, 6810 engagements


"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](https://x.com/TripleGateCaptl/status/1977391953768485250) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-12T15:12Z XXX followers, 23.8K 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](https://x.com/TripleGateCaptl/status/1977466051484078412) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-12T20:07Z XXX followers, XXX 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](https://x.com/TripleGateCaptl/status/1977671818736496775) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-13T09:44Z XXX followers, 4087 engagements


"Mao Lenin Stalin Ho Chi Minh Castro Marx Engels etc.all started in their youth with their "revolutionary" ideas to "help the working class." .millions and millions of people were murdered along the way and whom did their ideas help in the end For all the people who have been able to leave the USSR or any other socialist hell hole it's heartbreaking to witness the metamorphosis of the Democrat party in real time. Makes me happy to be old"  
[X Link](https://x.com/TripleGateCaptl/status/1979190357406425309) [@TripleGateCaptl](/creator/x/TripleGateCaptl) 2025-10-17T14:18Z XXX followers, XXX engagements