Farmas USA

LLBO

Dentro completamente, entraron las que faltaban, guay.

XOMA - PBYI - NVAX - SIMH - LLBO - NYMX

Ya llevo carga al lomo.

OCAT

Términos del crédito. No son malos, ¿no? Tiene que ser la razón de la subida de hoy: financiación a un 6,5% que disipa el miedo a la dilución a corto plazo.

Principal aggregate amount of up to $10.0 million, comprised of: (i) a $6.0 million term loan, which was funded at the closing ( the “Term A Loan”); and (ii) subject to the terms and conditions of the Loan and Security Agreement, an additional term loan totaling $4.0 million (the “Term B Loan”). The Loan and Security Agreement provides for interest-only payments through July 1, 2019 at a current per annum interest of 6.5%, subject to the adjustment described in the Loan and Security Agreement, and a final payment of 8% of amounts drawn. The Company also paid the Bank a deposit of $20,000, to cover legal costs associated with the Loan and Security Agreement.The Loan and Security Agreement provides that the Company shall repay the principal balance of the Term Loans in 36 monthly installments starting on August 1, 2016 and continuing through July 1, 2019. The interest-only period may be extended to 18 months based on certain conditions defined in the Loan and Security Agreement. The entire term loan principal balance and all accrued but unpaid interest will be due and payable on July 1, 2019.

PTN

Rojas, ver para creer.

OCAT

Una disección refutatoria del artículo por uno de los especialistas del foro por si a alguien le apetece saber más. Pongo entre paréntesis las afirmaciones del artículo de SA y lo que no las lleva es la contrargumentación del forero.

Regarding the section entitled «Ocata has conducted initial RPE trials with no control group and inconclusive results that should be heavily discounted»

"Cowen's report focuses on ridiculously high out year estimates of revenue potential while missing the most important aspect of Ocata: The clinical trial design is unviable, initial results are inconclusive, and significant safety concerns exist and will remain as an overhang on the stock for years to come while OCAT insiders never seem to miss a paycheck."

You have all seen me argue again and again that the phase 1 finding are promising and not binding. This does NOT mean that the study was unviable. I would entreat Mr. Mako to show me a phase 1 study that would, in fact, count in his mind as viable. Immunotherapy studies in oncology come to mind, and they are uncontrolled. Phase 1 is in its nature a preliminary trial.

"the FDA and scientific community have significant reservations about the long-term safety of stem cell treatments"

This is the central lie of the article, my main point of contention. To which I have only one real question (honestly, one I would like to use TOS-violating language to ask):

Why is Ocata running a safety trial?

The answer is: to establish safety. The safety and efficacy of stem cell-based therapies are not yet known. This is why we do the experiment. This is the purpose of phase 1. And some of these patients have been followed for over 4 years now. It's possible that hESC-RPE is tumorigenic, but we have so far not seen ANY sign of it.

Unsurprisingly, Mr. Mako focuses only on the followup report in Stem Cell, which included 4 patients. He decided to ignore the results of the Lancet report.

"In fact, quoting directly from the study: "The sample size in these studies (SMD phase 1: 3 patients; dry AMD phase 1/2a: total of 12 patients, with 3 for each dose) was not powered to detect an improvement in visual acuity." Yet, investors have placed false hope on this poorly designed study with results showing that even untreated eyes improved."

I'd like to see his qualification in judging the trial "poorly designed." He has demonstrated no aptitude for analysis of clinical or basic scientific data.

"If untreated eyes showed improvement, how do we even know if the stem cell treatment works at all? After all, there was no control group in the study.

If untreated eyes showed improvement, why risk stem cell treatments that could lead to tumors in your eyes?"

Again, show me any phase 1 trial that has a control group. He's is operating under the assumption that this study was designed to show efficacy.

Regarding the section entitled «Based on numerous other studies, there is significant ongoing concern about safety in stem cell treatments»

"The reason Ocata did not have a control group is these studies were meant to measure safety, but they failed in this regard as well because the study did not follow up for a sufficient period of time to prove the long-term safety in treated patients."

There's a good reason why the titles of the published articles include words like "preliminary" and "interim" and "first evidence." Read the conclusion of the seminal report from the Lancet. "Our results suggest that hESC-derived cells could provide a potentially safe new source of cells for the treatment of various unmet medical disorders requiring tissue repair or replacement." Nowhere does Ocata make wild conclusions about their therapy. There is risk here, but that risk does not equal a guarantee, as Mr Mako would have you believe.

"After reviewing the literature, my view is that there has been no convincing long-term safety profile demonstrated by Ocata or anyone else."

That's because the entire literature on hESC-derived tissue is essentially Ocata's publication.

"However, development of tumors in humans after stem cell treatment can take several months to years depending of various factors. Hence, the follow-up of just one year is a clinically inept approach to monitor the safety or the incidence of tumor development."

It is critical to point out the reference he cites as justification of this statement.

Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient "Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient"
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2642879/

His justification for stem cell tumorigenicity derives from a case study of A SINGLE PATIENT with a brain tumor following neural stem cell transplant. Note this: this patient unfortunately developed a brain tumor 4 years after receiving a transplant of fetal neural stem cells. It is difficult to say exactly what went wrong, but the use of this paper as justification is strong support for Mr Mako's lack of understanding in this space. Neural stem cells are not the same as embryonic stem cells. And RPE derived from ESCs are not the same, either. Ocata's assay for detecting pluripotent cells by cell sorting is highly sensitive, and it would pass muster as a test for minimal residual disease in current standard practice for oncology.

"If we look into the scientific reality, the Food and Drug Administration (FDA) considers ALL stem cell-based treatments/products are potentially carrying the risk of tumor formation"

No. From his own source. «FDA considers potential risk of tumor formation for 'all cell-based regenerative medicine (RM) products.» This means that companies need to demonstrate that their products are nontumorigenic, not that the FDA suspects all regenerative medicines are tumorigenic.

Everything Mr Mako cites from the FDA is with respect to the concern for tumorigenicity and how best to address it. This was all published before any significant safety data were published. Now we have the first safety signals.

"If we look into the available scientific evidence, it's clear that ongoing concerns remain - there is a lack of procedural and approval process standards in stem cell research that can create huge translational potholes (from animal studies to humans) in clinical applicability, treatment efficacy, and patient safety. Even in animal studies, transplantation of hESCs leads to tumor formation (teratoma) in hESC-transplanted mice. The clinical applicability of stem cell products is limited due to tumor formation."

There is a lack of procedural process standards because trials haven't yet been run. So should I conclude that these trials should not be run at all?

Congratulations on pointing out that transplantaing hESCs will lead to teratoma formation in mice. This is the reason it's a concern. Good thing Ocata isn't injecting hESCs in humans.

"Adding credibility to these experts' concerns, a study published by the National Institute of Health (NIH) has reported the risk of developing tumors (tumorigenesis) after human embryonic stem cell (hESC) transplantation. The title of the paper was, "Tumorigenicity as a Clinical Hurdle for Pluripotent Stem Cell Therapies." I'm going to go with the NIH on this one since they are both unbiased, and in my view, possess superior clinical and regenerative medicine expertise to Ocata."

He's going with the NIH on this one guys. The title of the paper says something that can be construed as scary. The content of the paper is actually REVIEWING the animal data and methods to help address the concern. There's nothing damning about this paper in the least, other than to point out potential challenges.

"The key sentence in the paper is, "[T]he intrinsic qualities of self-renewal and pluripotency that make these cells so therapeutically promising are also responsible for an equally fundamental tumorigenic potential." This is the problem that no one, including Ocata, has been able to solve yet. Don't waste your hard earned investment dollars chasing a long shot from a company with numerous other problems, as detailed throughout this report."

You mean the second sentence of the introduction is the most important of the entire paper?

"Echoing the FDA's concerns, a recent study has reported the development of pluripotent stem cell-derived tumors in patients who received stem cell transplantation for the treatment of ataxia telengiactasia (genetic disorder) and lupus nephritis (immune disorder), which took several years to develop. These findings raise several questions about the long-term safety of stem cell therapy. This is further reason to discount Ocata's 12 month study as "safe" - 12 month is simply not enough time to draw any conclusions."

First, every paper he cites just calls to attention the potential pitfalls of pluripotent stem cell therapy. Nowhere does it say that progress should be halted because of these dangers. That's an important point.

Second, tumors in the brain and spinal cord are notably more difficult to detect early in tumor progression. Would Mr Mako care to let us know when coherence tomography is able to detect hyperproliferation that might be indicative of tumor formation? Here's one hint:

SUBMILLIMETER CHOROIDAL MELANOMA DETECTION BY ENHANCED DEPTH IMAGING OPTICAL COHERENCE TOMOGRAPHY IN A PATIENT WITH OCULODERMAL MELANOCYTOSIS. - PubMed - http://www.ncbi.nlm.nih.gov/pubmed/26110523

In this case study, clinicians were able to detect the early signs of ocular melanoma using OCT. There's a very specific reason that the clinicians in this study are looking for signs of hyperproliferation. It's going to be the early signal that something's going wrong. So far, it hasn't been seen in any patients. So far, it hasn't been observed in ANY animal studies, which allow us to see aberrant cell growth at much much higher resolution than OCT would even allow.

"Testing and monitoring the tumor formation in animal studies involves several controlled laboratory studies called in vivo and in vitro studies"

I highlight this statement as an indication as to how little he really knows. In vitro studies are not in animals, typically more in cell culture. In vivo (literally, "in life") is pre-clinical animal work.

"So really the only thing to do is wait at least 4 years after the RPE treatment."

Then we should perhaps analyze the several patients who have had more than 4 years of treatment experience with hESC-RPE

OCAT

A juzgar por la captura de pantalla del artículo de uno de los foreros (25.02.2015) el artículo debe de llevar escrito algún tiempo y lo han sacado hoy justo tras la noticia por razones estratégicas lógicamente. ¿Cerrar cortos que ayer eran del 70%?

Mugi,,,,estas son capaces de romper aguas hoy mismo,,,,o mañana.

MEIP.

Pues vaya! Si lo sé las compro antes...jeje De hecho me he metido porque estaban animadas, y llevo tiempo detrás observando. Números bastante decentes para el tipo de chicharrillo que es, 2,06 o así en cash por acción que no está nada mal. En principio sin peligro de dilución (coger con pinzas...) en los próximos meses. Si sale alguna noticia positiva puede pegar un buen arreón!

MEIP

SIMH

Ni se mueven, secas, para mí que el cuidador no contaba con que yo me colase, y ahora no puede subirla. Estará pensando..."¿y como hago yo ahora para subirla sin dárselas a este cabrón que se me ha colado?"