Mickeychiku
@mickeychiku
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Navigating life with medically complex terminal disabled son. Biotech regulatory affairs. Stocks related posts are NOT for financial or medical advice.
United States
Joined February 2025
“FDA agrees with your current approach however final determination will be made during substantiative review of your commercial BLA or NDA application. We also recommend you to consider XYZ requirements outlined in FDA’s guidelines XYZ as per code of federal regulations 21 CFR
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$NKTR
@A_May_MD @Banana_Oncology A disease where top drug has 50% non responders. High numbers of patients with comorbidities who can’t take immune blockers. And just patient psychology to prefer safer drug with moderate efficacy over high efficacy drug with high side effect because of probable long term or
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Medically complex kid parenting: Life feels good when you don’t participate in anything and live in your own bubble. There was a social gathering in community today. V was in his stroller surrounded by 15-20 normal kids playing. He probably didn’t even have any idea what was
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After approved CRLs in July, I have now gone through each one of these CRLs released on Thursday. CRLs are humiliation for us. They stay on our forehead as mark of failure for life. We are judged by our ability to avoid CRLs, mitigate risks and identify all CRL risks atleast 1
Hey folks - FDA has posted more Complete Response Letters, including those sent to $CAPR and $REPL. My quick read doesn't reveal any issues / deficiencies not previously disclosed. You can find the new CRLs here: https://t.co/zd6b1MaWPy Let me know if you see anything
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$MIST Mist CRL is fully redacted but here is nitrosamine deficiency from 2023 epinephrine nasal spray filing. Mist must have received almost same deficiency word by word.
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$SRRK Regeneron has 2 BLAs impacted and SRRK has one. But, why regeneron’s one BLA already received CRL and other got extension? - so odronextamab BLA PDUFA was July 30th and FDA had not received any response from Catalent (Novo) till that date so FDA had legal ground to issue
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Good transparency but letters are mostly redacted for most of NDAs/BLAs. Something is better than nothing.
Hey folks - FDA has posted more Complete Response Letters, including those sent to $CAPR and $REPL. My quick read doesn't reveal any issues / deficiencies not previously disclosed. You can find the new CRLs here: https://t.co/zd6b1MaWPy Let me know if you see anything
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$NKTR Rezpeg should be tried in pediatric trials. These patients are high risk to infection and meningitis and they need a safe alternative. Huge unmet needs.
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$MIST One thing I forgot to write clearly above is that they had type A meeting around June 5th and they resubmitted NDA on June 13th (within a week). This is only possible if your proposed data/plan was verbally agreed as acceptable in meeting. You don’t go back to FDA in just
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Option traders, Trying to learn this. From what I’m reading everywhere online, almost everyone recommends never exercising even in the money call options. May be this is tech stock thing? On bio side let’s use $abvx as example. If this one had options and someone had call option
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$MIST There is one puzzle in Mist DD: - Mist in March CRL announced that the two issues are 1) Nitrosamine risk assessments 2) inspections requirement of a “release test” facility which changed ownership during NDA review. Change in ownership should not impact ability to
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$OTLK Well, efficacy issue is what I had seen in my DD but waited to post until after hours. Never ever bet on EU approval. EMA is very flexible. US FDA is whole another level. China NMPA and Japan PMDA are even more stringent than US FDA. Good luck.
$OTLK No position but did quick check on this on regulatory approvability in the morning. This can’t get approval. Many loopholes! Looks like ALDX to me. Good luck to investors though. Hope I’m wrong!
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$OTLK No position but did quick check on this on regulatory approvability in the morning. This can’t get approval. Many loopholes! Looks like ALDX to me. Good luck to investors though. Hope I’m wrong!
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$SRRK Just went through new 22 page FDA 483 warning letter issued on 07/14. There are many repeat observations. All of these are not procedural as many have claimed. I stand by my previous assessment that these can not be remediated within 3 months extended BLA review. All
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A father's last words before donating his heart to his son. ❤️
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It must have been great trading bio stocks between 2015 - 2021. MAb, cell&gene therapies, ADCs and Covid time boom. Looks like so many small cap bio stocks used to go 5x - 20x than very few today!
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My ideal A+ set up: - comprehensive clinical pitch by physicians or MD ideally from the same therapeutic area - my own regulatory feasibility assessment of clinical pitch. Regulatory CMC and risks assessment - robust financial analysis from a finance expert All above clear,
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Run from Bios that falsely PR that their IND received FDA “approval”. This is done to influence trial enrollment and stock movement. There is no such regulatory mechanism “to approve” an IND. IND becomes “effective” after 30 days of submission. After 30 days mark, sponsor is
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Medically complex child parenting: Just returned from my sons (V) nth hospital stay. Had some free time there so I again talked to the person I hate talking to, Myself. V will be 4 soon. V has spent ~ 40% his life in hospital. This stay was for a week. The longest single stay
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$SRRK Catalent (now NOVO) responded to FDA in week of Aug 4th on inspection findings from 2023 and findings from recent inspection in July 2025. FDA classified Eylea BLA today as major amendment implying whatever Novo responded early August is significant in nature and extended
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