RDUS
Jefferies maintained Radius Health (RDUS) coverage with Hold and target $38
Past Target Price: $34
Aquí tenéis las diapos de la presentación:
https://seekingalpha.com/article/4094721-radius-health-inc-2017-q2-results-earnings-call-slides
Aquí, la transcripción:
https://seekingalpha.com/article/4094719-radius-healths-rdus-ceo-jesper-hoiland-q2-2017-results-earnings-call-transcript
Todo parece muy bien, pero en la transcripción de la rueda de prensa se comenta un pequeño detalle que me ha hecho saltar todas las alarmas:
Resulta que EMA les ha pasado una lista de problemillas y uno de ellos es que dos de sus CRO no cumplen con las buenas prácticas y por lo pronto no aceptan los datos presentados por ellos. Esto parece que representa un 15% de la muestra del ensayo.
A la pregunta de uno de los analistas de si esos mismos centros participaron en el ACTIVE (que es el utilizado para la aprobación de TYMLOS de la FDA), la respuesta de la empresa se va por los cerros de Úbeda, y dice sencillamente que si se elimina ese 15% los resultados dejarían de ser estadísticamente significativos.
"we've also had setback on Eladynos with the CHMP. We have received a second set of day-180 questions. Although we continue to believe that Eladynos will be approved in Europe, recent regulatory challenges have post risk we will work to overcome." -> 21 de julio, día de la caída hasta 39,25
This second list of 180-Day questions includes two major objections related to our inclusion of data from two clinical trial sites that based upon EMA inspection findings are not considered to comply with good clinical practice or GCP requirements. If these data are excluded the statistical power of our submitted clinical data is reduced impacting statistical significance and the overall benefit risk assessment.
These questions include requests for additional data analogies related to the safety and efficacy of Eladynos and we are working collaboratively with the Rapporteurs and CHMP to address their questions. We have maintained full transparency with the FDA through their review and approval of the TYMLOS, NDA. The FDA assessment of TYMLOS included thorough and independent and statistical analyses and GCP inspections at key clinical sites.
Although we continue to believe that Eladynos will be approved in Europe. There are sometimes regional regulatory challenges to overcome and based on this second list of 180-Day questions we now expect the CHMP to issue an opinion on the MAA before the end of 2017.
Ronda de preguntas:
- On the CHMP topic; what percentage of the patients in the ACTIVE study were enrolled at the sites that you mentioned that the CHMP is taking issue with?
Respuesta: Greg Williams
Hi, Jessica, this is Greg Williams. Regarding the CHMP question. So thank you for the question. And first, I'd like to let you know we remain confident in the integrity of the ACTIVE and the ACTIVExtend data, and we were surprised by the second set of 180-day questions. We believe that it's important to be transparent with our investors and we continue to expect that Eladynos will be approved in Europe.
With respect to the two sites, about 15% of the active population would be impacted if we exclude those two sites from future analyses. However, we have seen consistent and favorable effects in fracture reduction across all the company sites. We look forward to working with Rapporteurs and CHMP and addressing their questions, and we look forward to an opinion before the end of this year.
En resumidas cuentas, que no me fío un pelo. El perfil de introducción en el mercado y cobertura de aseguradoras tiene buena pinta, pero está por ver que los profesionales comprueben sus efectos reales (y saber qué parte es promoción y qué otra ventas contantes y sonantes). No será el primer fármaco ni el último que no cuaje, así que, por lo pronto, salvo oportunidad muy buena de compra, la abandono.
Edito: coño, no me esperaba, no obstante, tanta caída en apertura...
«Después de nada, o después de todo/ supe que todo no era más que nada.»
