LunarCrush LLM | creator/twitter::1891984535258267649/posts

[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]

[@mickeychiku](/creator/twitter/mickeychiku)
"$SRRK Explanation for above pics: - CI was alternate manufacturer for Libtayo - one of major issue highlighted in CI XXX letter is lack of testing of incoming PS XX (source - XXX stat news shared in Aug) which is very important excipient in Biologics manufacturing and also used in Libtayo (source - dailymed) - So FDA likely asked Regeneron to remove CI from sBLA if they wanted approval and Regeneron did that. May file another CMC sBLA in future to add again if they want to. Overall todays news is bad news for SRRK"  
[X Link](https://x.com/mickeychiku/status/1976021362511839260) [@mickeychiku](/creator/x/mickeychiku) 2025-10-08T20:26Z XXX followers, 1588 engagements


"$SRRK FDA officially concluded - OAI"  
[X Link](https://x.com/mickeychiku/status/1977683741373026329) [@mickeychiku](/creator/x/mickeychiku) 2025-10-13T10:32Z XXX followers, 2312 engagements


"$SRRK I had no position but attempted to write how things work behind the scene in Regulatory world. Todays outcome was clearly visible from July the day CEO mentioned for the first time. Sometimes its just sequence of events and selection of words. Concluding the thread"  
[X Link](https://x.com/mickeychiku/status/1977718103451611529) [@mickeychiku](/creator/x/mickeychiku) 2025-10-13T12:48Z XXX followers, 4227 engagements


"$PRAX An immediate meeting to discuss data then PR and then offering would have been better approach. But then"  
[X Link](https://x.com/mickeychiku/status/1979005348955533562) [@mickeychiku](/creator/x/mickeychiku) 2025-10-17T02:03Z XXX followers, 3515 engagements


"1) FDA: Your data tells nothing. Add XYZ patient population to prove efficacy for approval PR: FDA was so happy with current data that we are adding new participants groups in next trial. 2) FDA: Your phase 1/2 product is in syringe which is combination product and you didnt even know. You need to include XYZ data in phase X IND and more for approval PR: To reduce COGS we will use vials in phase X and for approval. Better profitability. 3) FDA: Timing of study start is your internal decision. We dont care. PR: After aligning with FDA we are starting study earlier 4) FDA: Yeah your product is"  
[X Link](https://x.com/mickeychiku/status/1976350081465844008) [@mickeychiku](/creator/x/mickeychiku) 2025-10-09T18:12Z XXX followers, 9421 engagements


"$CAPR FDA staff are not personal friends to talk to. To talk you have to submit meeting request with clear agenda questions and your position. If you havent done any previously told work you will likely wont be granted any meeting to waste time. You will be told to look at their comments in CRL and past meetings. This is standard practice"  
[X Link](https://x.com/mickeychiku/status/1978574514826203640) [@mickeychiku](/creator/x/mickeychiku) 2025-10-15T21:31Z XXX followers, 4023 engagements


"@JoseRestonVA @A_May_MD Should we put BO possibility aside now that you are out"  
[X Link](https://x.com/mickeychiku/status/1979240283364528536) [@mickeychiku](/creator/x/mickeychiku) 2025-10-17T17:37Z XXX followers, XXX engagements

[GUEST ACCESS MODE: Data is scrambled or limited to provide examples. Make requests using your API key to unlock full data. Check https://lunarcrush.ai/auth for authentication information.]

@mickeychiku "$SRRK Explanation for above pics: - CI was alternate manufacturer for Libtayo - one of major issue highlighted in CI XXX letter is lack of testing of incoming PS XX (source - XXX stat news shared in Aug) which is very important excipient in Biologics manufacturing and also used in Libtayo (source - dailymed) - So FDA likely asked Regeneron to remove CI from sBLA if they wanted approval and Regeneron did that. May file another CMC sBLA in future to add again if they want to. Overall todays news is bad news for SRRK"
X Link @mickeychiku 2025-10-08T20:26Z XXX followers, 1588 engagements

"$SRRK FDA officially concluded - OAI"
X Link @mickeychiku 2025-10-13T10:32Z XXX followers, 2312 engagements

"$SRRK I had no position but attempted to write how things work behind the scene in Regulatory world. Todays outcome was clearly visible from July the day CEO mentioned for the first time. Sometimes its just sequence of events and selection of words. Concluding the thread"
X Link @mickeychiku 2025-10-13T12:48Z XXX followers, 4227 engagements

"$PRAX An immediate meeting to discuss data then PR and then offering would have been better approach. But then"
X Link @mickeychiku 2025-10-17T02:03Z XXX followers, 3515 engagements

"1) FDA: Your data tells nothing. Add XYZ patient population to prove efficacy for approval PR: FDA was so happy with current data that we are adding new participants groups in next trial. 2) FDA: Your phase 1/2 product is in syringe which is combination product and you didnt even know. You need to include XYZ data in phase X IND and more for approval PR: To reduce COGS we will use vials in phase X and for approval. Better profitability. 3) FDA: Timing of study start is your internal decision. We dont care. PR: After aligning with FDA we are starting study earlier 4) FDA: Yeah your product is"
X Link @mickeychiku 2025-10-09T18:12Z XXX followers, 9421 engagements

"$CAPR FDA staff are not personal friends to talk to. To talk you have to submit meeting request with clear agenda questions and your position. If you havent done any previously told work you will likely wont be granted any meeting to waste time. You will be told to look at their comments in CRL and past meetings. This is standard practice"
X Link @mickeychiku 2025-10-15T21:31Z XXX followers, 4023 engagements

"@JoseRestonVA @A_May_MD Should we put BO possibility aside now that you are out"
X Link @mickeychiku 2025-10-17T17:37Z XXX followers, XXX engagements