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Biotech Cat
756 posts

Biotech Cat
@BiotechCat
Biotech And More | Not Investment Advice | Will Make Mistakes, Always Learning | DMs Open
Inscrit le Nisan 2022
380 Abonnements2.8K Abonnés

@Vulpescap Personally, I don't see how it is that value-add specifically for clinical, but can't live on clinical-stage biotech alone and for a lot of other things it would be great, but the price tag...I just use thinkorswim platform that comes with my schwab account for basic monitoring.
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@Biohazard3737 Congratulations. To many good years for you and the team.
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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 review date.
Remember all SRRK and Eylea manufacturing process validations and stability batches would have been manufactured around 2023 under the process and site compliance status FDA has now problem with. FDA likely didn’t see any remediation done during July 2025 inspection and informed both Sponsors.
Now proposed remediation work Novo has submitted is called major amendment. This could mean the facility and equipment cGMP info earlier submitted is no longer simulating proposed commercial process. That could mean Novo needs to complete remediation first and both BLA needs to amended with details. Per SOPP 8402 max 3 months extension can be granted and remediation work might take longer than that.
Therefore, I see high probability of a CRL but I can be completely wrong. Please use your own judgement.
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@mickeychiku One day at a time! There are people out there who empathize with your journey! Not talked about enough.
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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 so far was for 282 days. More than an entire pregnancy. Rest ~ 60% life V has spent at home under extensive medical care. Even with medical complexity standard, V is worst affected. 22 diagnosis in single child.
If you add Covid years to this, ~99% of life in last 5.5 years we have lived either in a hospital or care taking at home. This has been a hell of a journey!
One day at a time! Fight continues! Good night!
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@sellsidepleb did you prewrite last week? assuming it is eps notes and models
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Victory lap (sorry!)
On a bit of a generational run. A combination of a lot of luck and incredible people to bump ideas with.
All of the ideas I’ve posted on X (for free) and will continue to do so.
$urgn 4 to 14
$nktr 9 to 23*
$cdtx 38 to 55
$rare / $mreo short w/ naked 40c sells
$abvx 8 to 70*
$celc 15 to 34
I’ve used options mostly as a defensive tool to manage risk (bar the $rare and $crdf shorts) and it’s taken me a few years and a blow up from 7 figs to improve my ability to handle size.
This could be as good as it gets although I hope it’s just the beginning of something even more special. What I do know is that I love this game and this sector $xbi changes lives.
*active positions

BioSurge Pawcio@pawcio2009
#Biopick2025 wk30. And here we go, official confirmation, new leader explodes into 1st 🚀💪👏 1. $abvx +808% 2. $rgls +416% 3. $sana +204% Individual leaders: 1. @seedy19tron (abvx) 2. @A_May_MD (rgls) 3. @tricoloredeel (sana) Full Standings: drive.google.com/file/d/1cBFTJo…
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Any good write ups on what happened?
Andrew Dowson@AndrewDowson
Boom 🚀 up 1000% 5 years! #RR @Ronmarkets2
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A reason to love #biotech: a company approaching the end (low stock price; near "death") can generate >20x return in a few, or even 1 year!
Though these deals are few & far between, here are some examples:
Adding $VRNA/$MRK
#learnbiotechinvesting #investing #BiotechPrometheus

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agree
I would be more interested in what was true value driver and simple non-obvious insight
though not sure how much to tease out
example if i remember probably ambrx acquired for linker tech? or cymabay artifact from scans you didn't need to spend much time to see dislocation?
sort of asking the question why do stocks go up
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@BiotechCat @learnbiotech Good thread would be sentiment at the bottom, the key value driving events and ultimate phase and situation before approval
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