mets17
24.4K posts


@JMaraganore @US_FDA What about looking the other way selling out us job and security to China we ok with that ?
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It is disappointing to see these @US_FDA staff departures. Bringing innovation to patients requires a strong and experienced agency!
Jason Mast@Jasonmmast
Nicole Verdun, director of the cell and gene therapy office, has been placed on forced out of the FDA statnews.com/2025/06/18/top…
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@AppleHelix biospace.com/genscript-and-…
They did do this …
I mean if USA doesn’t act quick the entire bio industry will go away like manufacturing
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@plainyogurt21 @houndcl @Michaelrose102 @Sanctuary_Bio @MelvinRiskMgmt can my favorite MLB athlete start taking this to avoid injury
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@houndcl @Michaelrose102 @Sanctuary_Bio @MelvinRiskMgmt Waiting for a shkreli like entrepreneur to buy a drug like this and explicitly sell it to high end clients only. Charge 50k/ year + combo with GLP so they don’t have to exercise and stay fit.
Plenty of rich people out there who would pay for it…….
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@Sanctuary_Bio @BayAreaBiotechI old presantation they wanted to partner this out
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@adar170 @BayAreaBiotechI dont think so...keep apitegromab for rare disease, 439 for cardiometabolic was logic previously
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@Sanctuary_Bio @BayAreaBiotechI also wouldnt trying for obesity kill pricing for sma?
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@adar170 @BayAreaBiotechI well I mean you don't have to think it lol...it's basically confirmed now
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@Sanctuary_Bio @BayAreaBiotechI i think they want to stick to rare dgx and not involve in crowded obesity field
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@adar170 @BayAreaBiotechI yea you have to wonder what's going on behind the scenes. Why move from Chairman to CEO. I suspect vast differences in ideology
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@BayAreaBiotechI the interesting thing is that as recently as the Q1 ER the focus on 439 was still cardiometabolic. alxn bros hallal and sinha joined in late april. Quite the strategic shift
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@Sanctuary_Bio @MelvinRiskMgmt @houndcl @plainyogurt21 @A_May_MD mostly fired for stupid brazil witch hunt
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$SRRK weight loss/muscle preservation data look good IMO. People I know have been watching for this to be a “sell the news” event to buy more for SMA oppty. Not sure any significant “sell the news” reaction happens from these data.
Very slightly less weight loss (1.1% delta) on the combo arm is fine. $REGN saw slightly *more* WL with their combo but there are major caveats here. $SRRK was combining with TZP whereas $REGN was with sema. TZP weight loss is significantly more than sema’s at 24 weeks, so any combo with TZP is going to take longer to show greater weight loss than a sema combo IMO. On top of that, $SRRK’s study was 2 weeks shorter than $REGN’s.
$SRRK preserved more lean mass and lost a great proportion of weight (again, TZP caveat).
Ultimately in 1 year+ studies I think these myostatin regimens are going to show increased weight loss overall, on top of much larger fat loss and more muscle retention. How could that *not* lead to better cardiometabolic outcomes long term?
Myostatin is the way to go here IMO. Broader MOAs won’t have the clean safety required, and myostatin alone actually seems to be getting the job done.
I’m impressed. I think myostatin+GLP-1 is going to be a legitimate approach that multiple phase 3 studies are run for. Hopefully ultimately getting commercialized…long way to go on that front obv.
$REGN in the lead? $SRRK and $IBIO in pursuit. $BHVN and $LLY with broader MOAs that I’m less fond of.
Maybe $SRRK gets sell the news today, IDK. In the $30s I still think it is undervalued on SMA alone.
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No, you're misunderstanding. I am simply saying, brand awareness in the case of HCV/HIV leads to higher tx rates (good)...regarding IO, you do see patients come in aware of Opdivo/Keytruda...in the early days of IO, chemo-disciples of community oncology didn't automatically prescribe them, despite the Ph3 KN-189 study etc...so in these few cases, DTC was good. The vast majority of DTC is completely useless though. I was just highlighting a few good examples.
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@BiotechObserver @adar170 It’s not bad it’s good. Drives patients to seek care.
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@abbynac @srqstockpicker with no middle class by 2032 hope you ready for socialist prez
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I hope the Democrats make Omar their leader and spokesman
End Wokeness@EndWokeness
Rep. Ilhan Omar: "We are turning into one of the worst countries on earth"
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FAQ here:
1) Seems the Commissioner is the sole decision marker on who gets one
2) Non-transferrable
3) Expires 2 years after issuance. Most biotechs won't be able to use it. Maybe through a merger w/ another company??
fda.gov/news-events/pr…
Jing Liang 🇺🇦@AppleHelix
WOW!!! This "National Priority Vouchers" program is just wow! fda.gov/news-events/pr…
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@sharkbiotech @Sanctuary_Bio @MaxJacobsCFA @AppleHelix the non transferable of PRV hurting a lot of rare dgx today imo
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@A_May_MD @sharkbiotech @adar170 I think the real relationship is paying the networks for favorable news coverage (or minimal negative coverage) and advertising makes a convenient way to move the cash.
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@sharkbiotech @A_May_MD even the $HIMS supr bowl ad backfired badly imo
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