ATHX
De aquí a verano no van a sacar nada. Teniendo en cuenta además que estamos en mayo, yo esperaría a una mejor oportunidad de entrada. La verdad es que la empresa me gustaba bastante hasta que oí por ahí que tenían mal diseñados los ensayos. Supongo que a partir de ahora tomarán nota. Creo sinceramente que las células pueden funcionar para los infartos de miocardio, pero lo que no tengo tan claro es que sean capaces de dar células autólogas a nivel comercial en menos de 36 horas en ningún caso. Como no tengo ni idea de números, no sé si es buena entrada o no (que se lo mire alguien), pero como no tengan mucha pasta a mano, cosa que dudo, la dilución será inminente. ¿Sabes cuándo fue la última?
De la conferencia:
our reported net loss does not include any impact from the Chugai collaboration
Included in the 2015 first-quarter cash from operating activities was $8 million of the $10 million upfront payment from Chugai associated with the collaboration in license agreement. $2 million of the upfront amount was temporarily withheld by the Japan taxing authorities and will be refunded to us under the U.S. and Japan tax treaty.
we have the potential to receive an additional $45 million of development-related milestone based payments including $7 million this year following Chugai’s review of the data from our Phase 2 ischemic stroke study. Additionally, there are approximately $150 million of future sales milestone based payments based on current exchange rates. We’re also eligible for royalties on that sales starting in the low double-digits and increasing incrementally to the high teens depending on net sales levels. -> De esto, olvidémonos en mucho tiempo
the initial results from the trial show that MultiStem exhibit the consistent safety profile and also suggested it has the potential to substantially improve clinical outcomes for patients if it is administered within an appropriate timeframe: además de lo que decía de que es casi imposible que los pacientes vayan a recibir la inyección de células autólogas en 36 horas en un contexto normal, está por ver que a las 36 horas vaya a servir de algo
If the results for patients receiving MultiStem therapy within 36 hours or confirmed in future trials-> yo aquí leo entre líneas que dan por sentado que van a tener que montar otro ensayo
We are actively engaged in site initiation and launch activities related to our Phase 2 clinical trial evaluating the safety and efficacy of MultiStem administration, the patients that have suffered serious heart damage, as a result of a myocardial infarction, and preparing for the initiation of a clinical trial evaluating the administration of MultiStem the patients that have been diagnosed with acute respiratory distress syndrome -> Esto es lo que debería hacerla subir, pero por lo que dicen después no lo sabremos hasta el próximo informe trimestral, es decir, que no nos llegará hasta agosto por lo menos
Based on the progress of the past two years, we recently were notified of the award of $900,000 for the final phase of grant funding, which has been supporting our work in traumatic brain injury, and we recently received a perfect score on an SBIR grant application from NIH reviewers related to our work in acute spinal cord injury. -> una noticia sobre la concesión de pasta la subiría sin duda.
Refiriéndose a los resultados del estudio: I think that over the next several months we’re going to get greater clarity on what that path looks like and our goal is to really have it pretty well mapped out by the end of this summer -> sacarán noticias de resultados positivos con minado de datos. Esto hará subir la cotización temporalmente.
Sobre el estudio anterior de la colitis ulcerosa con Pfifer: by the time we got out of the 8-weak assessment, we weren’t seeing anything or we weren’t seeing anything meaningful. And so I think that that ultimately let us to the perspective that in order to really assess this in the way that I think would be required, we would really need to do a study where we’re looking at multiple dose administration and perhaps even several different dosing regimens to try and gauge, what’s the right approach to be able to achieve a more robust therapeutic effect and something that is more durable as well -> confirmación de lo que decía de que planifican mal los estudios
In terms of the biomarker analysis, I mean, again we saw some things that were suggestive, some other things that didn’t really appear to reinforce any substantial activity at least based on those biomarkers. Some of the biomarker analysis was actually never completed or fully analyzed and so I think that remains something that we’d like to pick-up at some point. -> más minado (Colitis)
It is premature to project right now just exactly what the next phase of clinical development or as you put it the significance of that burden, what that’s actually going to be, because I think we have a number of interesting design options and choices about what we might elect to do next.
We want to make some meaningful progress over the course of this summer, and it’s probably going to happen in a few different iterations, and it’s going to be meetings with each of the regulatory authorities across the major geographies that we care about -> ningún anuncio de inicio de estudio próximo
one option would be to run a Japan-centric study, another option will be to run an international study which Japan - sites in Japan are part of. And you can imagine if we decided to run a Japan centric study you could design that in a number of different ways or even the international study which would be consistent with either utilizing the accelerated approval pathway in Japan or going for more traditional form of approval, which alleviates the need to invest in some of the downstream follow-up studies or other things that might be required under the conditional approval pathway
we kind of leg into stroke study that will have some impact on expenses, but we’ll provide some more guidance about that as that time approaches. -> Aquí indican que van a tener el mismo quemado de caja que este último año.
With respect to AMI, we’ve launched the activity there. There is a lot of work still to be done. We only have the first sites through the process. we’re going to have several other sites that we add here in the near-term, again I think that’s something we’ll provide some guidance and update on perhaps in the next quarterly call.
http://seekingalpha.com/article/3172106-athersys-athx-ceo-gil-van-bokkelen-on-q1-2015-results-earnings-call-transcript
«Después de nada, o después de todo/ supe que todo no era más que nada.»