SP Gab cerrado y como dije si sólo se quedara en eso,,,,,,, Al final verde por los pelos gracias a AMRN. Volviendo al original que haría mucha más pupa. A ver si no se da.
Si te sientas en la mesa y no descubres al "primo" es que lo eres tú.
Ivermectina, copio un post que he puesto en IV contestando a uno de estos que solo pone información falsa. Aparte de algún enlace sobre algunas de las cosas que mienten, al final resumen del fraude de los estudios que decían que la ivermectina funcionaba.
As background we have publicly bolt-gunned a number of studies of ivermectin. I don't mean niggled, I mean put down, here's a selection of the most important:
- Elgazzar
- Carvallo
- Cadegiani
- Samaha
- Niaee
Elgazzar: Contained fake data. Extreme terminal digit biases, duplicated patients, deaths in repeating patterns, deaths in control arm before study began
Carvallo: Contained unexplainable inconsistencies in between registry and paper. One of their recruitment centres states never participated. Statistician blamed for errors was not actually involved. Won't show data to own coauthors:
Cadegiani et al: contains impossible dependencies between consecutive patients (eg if one patient was physically active the next was 11 TIMES less likely to be), across multiple variables, no author could provide any explanation:
Samaha and Raad's dataset is trivially fake, and composed of blocks of 11 patients repeating in one arm and 17 patients repeating in the other. Even many of the authors on the paper accept it is fake and are arranging retraction.
The Niaee dataset claims to be randomised but includes extreme mismatches between arms at baseline. The chances of these range from thousands to one against to hundreds of quadrillions to one against:
Was concerned about AC PDUFA, which wasn't a sure win. If CRL, could have had -ve implications for DE trials, in terms of FDA support.
Now, the script is completely flipped. FDA clearly sees benefit of OCUL punctal platform imo.
With AC approval, $OCUL sales reps can get into doctors' offices and no longer have to worry about OR/ASC protocols
While Dex approval is for AC, reality is docs will use this for any inflamm where a short term steroid will be useful: patient convenience will be the big driver
If mgmt can get reimb back to where it was (which is expected?), procedure fee can be another big driver
Increases off-label use, for eg: the indication that OTX-DED is targeting, but if comorbid AC (which is common) then used on-label
Likely turbo-boost for Dex 2022 sales
Implication for OTX-CSI (different active ingredient) more about FDA support for P3.
CSI works, plug works, CSI+plug should be easy win (hence quick enrollment despite upsize, +ve doc feedback) Note: P2 trial not powered for stat sig, only n =40 per arm, look to see +ve trends
What AC approval signals: FDA prolly allows OCUL to design P3 immediately and perhaps the way mgmt wants to design: vs fast degrader control
What to look for in CSI results (coming soon): +ve trends AND decision to move into P3 trials, if with near-term timing, even better
Finally, OTX-TKI in wAMD:
$EYPT has a binary readout on EYPT1901 at AAO Nov 13. Have changed view on this readout (will get into separately) and now lean +ve (disc: re-long)
If +ve, this validates $OCUL OTX-TKI (updated Aus data as poster at AAO), with US data incoming Feb '22
Summary:
Most risky catalyst (AC PDUFA) done and +ve -> boosts near term off-label & on-label Dex sales
1) establish reimbursement in the office setting 2 years before dry eye approval & allows Dextenza to move to office
2) AC approval builds confidence in rest of pipeline & CSI approval path given AC efficacy wasn’t great
3) off-label dry eye usage
If a patient with Allergic Conjunctivitis shows up with comorbidity of dry eye it isn’t off label. AC sales could be bigger than expected if $OCUL positions AC this way. Can bundle with Dex and discount incentivizing docs more on top of procedure code pay
-You mean bundle Dex and CSI? Dex label specifies lower punctum, and even if it didn't I'm not sure occluding both puncta in an eye is feasible.
I meant selling both products to the same doctor. Strategy that works really well with competitors like Eypt. The classic Allergan Botox model. It becomes so much harder for competitors to compete given the amount of money the docs make on the various products.
No sigue con la primera generación (que era inaprovable como comenté) y el contrato con EU queda cancelado. Era muy obvio y cuestión de tiempo. Espero que con todas las advertencias que he ido haciendo por aquí nadie estuviera.
peleando la MM50 diaria ... yo aqui soltaba lastre pero Nachete no me deja ... >_<
Pero el dedo gana, fuera 5,21 desde 4,95 y con eso termino el dia por hoy, creo ... porque estoy mirando de reojo a las NVAX pero no me hacen tilin nada nada, para que forzar, paso hasta que mejore algo el asunto
