Farmas USA

En la pre ahora mismo subiendo el volumen y con un 3% a 1,33.

90k acciones y 1,37
CLSN

http://www.nasdaq.com/symbol/clsn/premarket

Son pacientes metatásicos muy jodidos. Lo normal es que la palmen. Míralo al revés: en 300 pacientes ha habido mejoría con el Thermodox ;)

Nos a acercamos al volumen medio y solo llevamos 50 minutos.
CLSN

Mi duda es, el mercado espera que la empresa presente algún tipo de novedad, dato, etc.

si no dicen nada nuevo creo q volveremos sobre los 1,10 / 1,20 en espera de nuevos acontecimientos dentro de un mes, pero si dan alguna esperanza fundada de éxito o del acuerdo con los chinos, esta tarde nos podemos ir a los 2 $ sin problemas.

MACK

Ha tocado los 6'25 y se ha dado la vuelta. Dedos cruzados y culo apretado.

El "mercado" esta a la espera de oir , en algun contexto no negativo, las palabras CFDA y FDA.
CLSN

ACTC

Si alguien quiere entrar en ella, hoy es el día, que pierde un 5%. Están un poco atrasados y los números son peores que el año anterior. Todo parece justificado.

La entrada en un mercado organizado se acerca:

we’ve been working very diligently with the SEC, making progress, obviously it’s been slower than we hoped, but we feel that we’re heading in the right path. We feel that we’ve got a very strong resolution to this and hope to be able to announce something relatively soon. We recently hired Ted Myles, an experienced Chief Financial Officer, who I expect will guide us through the next steps toward listing on a major exchange

Posible catalizador cercano con la publicación de estudio en ratas:

That paper is working on being published right now. Both our team and our collaborators are working on it, and it is, I guess you’d say it’s in final stages of preparation and then of course needs to be submitted and reviewed

Párrafos de la conferencia de hoy:

The company reported a net loss of $6.6 million for the three months ended June 30, 2013, as compared to a net loss of $4 million in the same period in 2012. Net cash used in operations for the 2013 second quarter was $4.2 million, compared to net cash used in operations of $2.9 million in the same period in 2012. This increase in operating cash utilization was directly related to our increased operating loss, which of course, was driven largely by our increasing clinical trial activities, as I mentioned previously.

Despite this increase in our rate of cash utilization, we did manage to strengthen our balance sheet slightly. Our cash balance as of March 31, 2013 was $4.1 million and we ended this quarter with $5.5 million on hand.

We believe that the combination of our cash on hand and the $20 million that we have available to us under our agreement with Lincoln Park Capital will provide runway to fund our current operations into the middle of 2014

Our financing strategy includes attracting capital from long-term institutional investors, uplisting to a national stock exchange and funding our ongoing clinical activities and exciting pre-clinical programs through several value inflection points.

FDA and our Data Safety Monitoring Board, allowed us to treat patients with better vision as good as 20/100. These patients are likely to have more photoreceptors that can be rescued. We remain confident that all surgeries on the remaining patients in this group will be completed in time for a complete data review at the company’s Ophthalmic Advisory Board meeting in early October.

-> we are treating much earlier stage patients now, which is really amazing for a Phase I trial, and I think speaks volumes about what the DSMB and the FDA feel about the safety of this trial today

We have observed the persistence of visual acuity gains and the engraftment of the transplanted cells in both the SMD and AMD patients, which is consistent with what was previously reported early on the trials.

A critical part of our evaluation is to further clarify what factors will help us to identify the patients who will benefit most. The clearance to complete treatments in patients with higher doses of RPE cells and patients with greater visual acuity represented significant milestones in our clinical trials

Some patients cannot tolerate the immune suppression and may no longer be eligible for treatment. Unfortunately, this only becomes apparent once the process has started

There is continued interest among big pharma companies regarding a joint venture or some other form of partnership, as every major pharmaceutical company with an ophthalmology program is watching these trials very carefully. While that is exciting to us and we know to you as well, we also know that clinical results will drive those collaborations. These deals take time and we’ve recognized the importance that Phase II trial design will play in the discussions.

In terms of costs, our current marginal cost of manufacturing a dose is sub $100 per dose. That is running just a single shift in the manufacturing facility in Marlborough, and we currently have sufficient cells for all of Phase I and Phase I

We’ve really not seen deterioration in the visual acuity of any of the patients. So that’s pretty surprising from our perspective and something we’re very pleased with. This is a degenerative disease.

There is no big pharma or biotech company that has an ophthalmology division, that doesn’t know everything about these drugs.

This is a potential multi-billion dollar therapy, and obviously, we’ve got a long way to go from here to commercialization. But you are incorrect if you think that I’m going to rush out and do a deal with one of these guys that you mentioned, just to get a deal done, can’t be foolhardy. We’ve seen too much promise in this therapy to just partner it out for a small upfront payment, it will be crazy.

Compassionate use, we are evaluating with our partner in Europe, our regulatory partner, the possibility of a Phase II pivotal trial, and that’s something that we’re in discussions with. we have some meetings over there in September. And obviously, we like you we’d like to get this into compassionate use and commercialization as quickly as possible.

We have many interesting pathways with the agencies, both because of the Orphan designation and a possibility of this breakthrough technology designation and it’s something that we obviously are going to aggressively pursue. We think that we’ve demonstrated - we’ve been very facile with the agencies; we’ve gotten all the protocol changes approved that we asked.

http://seekingalpha.com/article/1617852-advanced-cell-technologys-ceo-discusses-q2-2013-results-earnings-call-transcript?page=5&p=qanda&l=last