Re: Farmas USA
TGTX
Ya han liberado PR sobre lo que presentaban en londres. Yo he puesto orden de venta a 7,50 como dije ayer(también por tema opciones).
TG Therapeutics, Inc. Announces Presentation of Data from a Phase Ib Clinical Trial of TG-1101 in Patients with Neuromyelitis Optica (NMO) at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis
http://ir.tgtherapeutics.com/releasedetail.cfm?ReleaseID=989405
A single 450 mg infusion of TG-1101 (ublituximab) rapidly and effectively depleted B-cells during acute NMO relapses without significant risks in this patient population
TG-1101 was well tolerated, with minimal adverse events and no SAEs or infections observed
Timed 25-foot walk and visual acuity, NMO-specific functional measures of recovery, improved along with EDSS scores in patients treated with TG-1101 in combination with corticosteroids
Re: Farmas USA
Re: Farmas USA
Re: Farmas USA
post de BBALLGM, ya sabeis que respeto a este forero de Yahoo
What can I say...nothing is guaranteed in Phase III. And I lost a big part of my net worth on today's results, although a lot that net worth was made by Novavax. It sucks.
Anyways, we can either cry about it or analyze if this is salvageable. Well let's see.
There is definitely cause for concern. The re-dose phase II results are very strange....the Placebo-Vaccine group data is counter-intuitive because it is higher than the Vaccine-Vaccine group, yet it has worse efficacy data even with the highest titer.
Let's then look at the Phase III data. The vaccine group looks exactly like the placebo group, and that is not good. So the first question that comes to mind is why is it so different than the Phase II data. Why is the attack rate in Phase III less than HALF of what was seen in Phase II? I've been thinking about this for awhile, and it is a good thing they ran the re-dose trial because that also showed very low attack rate. So if we compared the placebo groups between the Phase III and Phase II redose trial, they match very closely...so this would indicate that indeed the attack rate is much lower for Phase III, just a chance of bad luck perhaps.
I would really want to the Kaplan Meir curve for this Phase III trial to see if it was really a low attack rate this season, or that Novavax started enrolling for the Phase III trial too late in the season. The original Phase II trial started in October 2014. The Phase III and Phase II redose trial both started in November 2015. So does 1-1.5 month difference in trial start make that big of a difference? It could be the reason for the lower attack rate. I want to see if the Kaplan Meir curve, and if there is a big drop at the beginning of the curve which may indicate the trial was started a bit late, and the RSV season has already started. Typically, RSV season onset starts in late October. Every season is a bit different, some start later and last longer.
What I mean by cocooning is that Novavax may have enrolled too many people within a short period of time within the same community. This may be a stretch, but something to look into.
If we look at the Phase III breakdown of enrolled patients...basically 100% of the enrolled are in community living...which is typical of elderly since they need assistance and probably living in group homes. And they probably tell each other about making some cash with being in the trial, so if I was Novavax, I would look at how close are the patients living with each other. The thought is that if they are all from the same neighborhood, and if the RSV vaccine is working, then the overall RSV incidence will be lower than usual. Since this is a virus, it needs hosts to spread the RSV, so 1 person infects 2 people, and those 2 people infect 4....so on and so on. Now if you start introducing a vaccine into a group of people who are in the same neighborhood, then you effectively lower the incidence rate because you stop the spread from the beginning. 60 sites for 12,000 people...so roughly 200 elderly per site. That's not too much considering how many elderly are there, but they need to look at if there are clusters of the enrolled living in the same community. Especially if they were being recruited heavily or if they go to the same elderly center. I've seen where they go to the elderly center, and just advertise to make some money, and the elderly is bused to the clinic in groups. Easy and quick recruitment. Just something to look into when the break down the site by site, and perhaps interview some patients on how they were recruited or look at the addresses / community centers.
If I was Novavax, I would start another Phase III trial, but I would want to start the enrollment at end of September/start of October, and perhaps spread out even more sites and make sure the recruitment is not from same community area.
Same goes for their Phase II redose trial
NVAX
Re: Farmas USA
Lo siento por los invertidos.
He borrado 15 veces el post. antes de colgarlo
Aprenderemos de una puta vez? el que se juega los eventos tiene que saber que es una lotería y obviar todos y cada unos de los comentarios, riesgo puro y total, la palabra de-risked no existe en Farmas, no es compatible.
La palabra BO y las especulaciones mejor en la mente de cada uno que después nos confundimos.
Grabar a fuego, Loteria, Loteria, Loteria.
En todas las farmas siempre tienes cosas positivas y negativas antes de resultados y no te metas a analizarlos porque si estás invertido, como estas invirtiendo con la emocion todo lo ves positivo.
Y da igual lo que analices, vas a fallar y te vas a equivocar, lo único que importa son los resultados.
las hay con 90% de institucionales y fallan las hay con un 10% y salen bien, precios objetivos altísimos y fallan, bajisimos y salen bien, no analicéis, Loteria, cortos por un tubo y salen de puta madre o viceversa, no hay análisis que valga, solo valen los resultados.
Hay que aprender de esta. Yo me he estallado ya unas cuantas veces y me seguirá pasando, lo bueno es que ya desde hace tiempo tengo claro que es una lotería.
Alguna vez una buena cagada sirve para que aprendamos, mucha suerte, que estoy seguro que vendrá.
Re: Farmas USA
Pues si Novavax piensa lo mismo hasta finales de 2017 no empezarán el ensayo en el hemisferio norte aunque lo podrían empezar antes en el hemisferio sur. Los datos esterían disponibles para mediados-finales de 2018. Mucho tiempo sin noticias para mantener las acciones en cartera.
Quizás esa confirmación durante la conferencia del 11 le puede dar un pequeño empujón al día siguiente pero nada más.
NVAX
Re: Farmas USA
Realmente los ánimos en el blog de Nasdaqlandia están por los suelos... creo que entre todos llevaban un pastizal... no recuerdo la cifra exacta, pero un día la comentó Framus y era de aúpa.
Ana, Superfungui es el autor del blog. Se llama Ramón, y a veces se refieren a él por el nombre. No creo que ande por aquí (si lo hace utiliza un nick totalmente distinto).
NVAX