yo no sigo ACST ni me interesa mucho, así que tampoco he leído su IR. Te pongo a ti "deberes" para que hagas más DD y encuentres tú posibles respuestas. Ha sido trilogy 2 (que parece ahora han retrasado a febrero) conducido en los mismos sites que trilogy 2? Parece que el fail del trilogy 1 ha sido en parte debido a un gran efecto placebo. investiga si, para empezar, el trilogy 2 se ha hecho en esos mismos centros (en concreto hay 5 donde el placebo se disparó) y encuentra explicaciones lógicas a porqué han separado trilogy en 1 y 2.? saludos y suerte
Añado que salga lo que salga en trilogy 2, los ensayos enteros del CaPre deberían ir a la basura. ya que la FDA que se supone que va a decir con un trilogy negativo y otro (aun por ver,) con hipotetico distinto outcome?
AMRN Crónica del juicio en curso por el tema de violación de patente
Key Takeaway
Day 2 of AMRN trial was a bit more balanced in our view with both parties making strong cases for/against the induced "infringement" claim. Today concluded w/ the Judge dismissing the defendants' request for an immediate ruling on the induced infringement claim citing AMRN has met the initial burden of proof to continue the trial. Although that ruling was in AMRN's favor, we think the induced infringement claim will continue to be argued by the defense.
Insights
Summary: Today began w/ direct/cross-examination of AMRN's expert cardiologist Dr. Matt Budoff. Following redirect of AMRN's witness, the defense asked the judge to rule on the induced infringement claim, stating they believe AMRN failed to meet the burden of proof. Following 5-10 min presentations from both parties, the judge indicated she would need more time to formulate her ruling. The day ended w/ the Judge dismissing the defendants' request to rule on the infringement claim citing the initial burden of proof had been met. We continue to think AMRN is in a good position in the case.
A majority of today's proceedings focused on the induced infringement claim and interpretation of the label; there appears to be more room for debate than initially thought, however. Recall, AMRN is claiming HIkma/Reddy's generic label induces infringement on AMRN's patents that cover treatment with Vascepa for 12 weeks or more. During direct examination, AMRN's witness Dr. Budoff reviewed severe hypertriglyceridemia (SHTG), the label, and systematically provided his reasoning as to why a majority of docs prescribing Vascepa would use it for "chronic treatment" thus any generic using the current label would infringe on AMRN's 12wk+ patents.
During cross-examination, the defense noted nothing in the label explicitly indicates Vascepa has to be used for 12wk+ and highlighted AMRN's own internal and expert testimonies that indicated SHTG could be an acute phenomenon and the label does not limit the drug for chronic use only. Dr. Budoff defended his earlier testimony well by stating if the drug is used as indicated by the label, all acute reasons to use the drug would be excluded thus providing a counterargument to the defense. While the judge has not tipped her hand on which way she is leaning through comments or questions, she has shown keen interest throughout the trial in the defense's arguments and to us looks clearly willing to accept to new information. The bottom line is whether the judge would rule in favor of AMRN because a majority of docs will use it chronically - or in favor of generics because there are situations where "acute use" is OK and that is sufficient to not infringe. That said - the Summary Judgment before the trial did suggest the argument by the defense was weak.
The judge appeared to really mull over the defense's motion to immediately dismiss the induced infringement claim. The judge concluded based on Dr. Budoff testimony, which stated if following the label, "most docs" would prescribe generic EPA chronically, the plaintiff has met the initial burden of proof. It will be interesting see how her interpretation may change following examination of the defense's expert cardiologist witness.
Parece que las tensión de las relaciones con China no se relaja del todo
Despite the signing of a "Phase One" trade deal this morning, it looks like some tensions between the U.S. and China will persist, triggering stocks to dip across the globe overnight. Existing tariffs on Chinese imports will remain until the completion of a second phase trade agreement, meaning the duties are likely to stay in place until after the American presidential election in November. The period of review is intended to give the Trump administration time to verify China's adherence to the terms of the pact, which will likely require Beijing to buy at least $200B of goods and services over two years, and to go beyond prior commitments made on IP and technology theft.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
Clovis Oncology’s Rubraca® (Rucaparib) Granted FDA Priority Review For Advanced Prostate Cancer
Clovis seeks U.S. approval for rucaparib as monotherapy treatment for patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer
- FDA submission based on data from TRITON clinical program in advanced prostate cancer
