Re: Farmas USA
REGN +4%
REGN +4%
CEMP. NO porque el stock esta halted hasta el lunes.
por lo que he leído hasta ahora el adcomm no está yendo tan mal como se podría deducir del adcomm document que hizo que el stock cayera 60%. Por el panic selling. Ahora están en un receso de la reunión.
CEMP
Porque saldrá hoy al cierre.
Empieza la Adcom ahora mismo si alquier quiere seguirla:
«Después de nada, o después de todo/ supe que todo no era más que nada.»
Short covering generalizado por oversold en el sector, lo que sea con tal de alejarnos de los 240 y ganar tiempo.
Mi objetivo ya no es tratar de ganar pasta aprovechando el dip electoral.
Ya solo quiero recuperarla. Estoy viendo pisos y mi mujer me ha dicho, literal, 'lo sacamos de la cuenta de las farmas, no?'
Me acaban de capar. :)
Es lista tu mujer. Tendrás que aprender a tradear con menos pasta :-p
«Después de nada, o después de todo/ supe que todo no era más que nada.»
AERI
La rueda de prensa de ayer:
at the end of every year we always have the option of filing any new information that we have either from completed trials or ongoing trials, like we did for example with Rocket 4 or Mercury 1, et cetera, but we have to decide whether we're going to file it to the IND or to the NDA at year-end. Our strategy was always to do that to the IND in terms of the data from Rocket 4 or Mercury 1, but as we said last week, since we now have a January resubmission date, we now expect that we'll add the data from both of those clinical trials, i.e., Rocket 4 and Mercury 1, certainly the efficacy data, short-term safety, we'll add that to the NDA when we re-file it
Rhopressa NDA filing is expected to be delayed by about five months from the original filing date, assuming again that we file in January of 2017. We think that we'll get the NDA approved as you know early in the first quarter of next year, right, because we'll file this January, so we're looking for a year from now, a year from January to get approval
visiting Ireland next week and hopefully negotiating a successful lease agreement for our own manufacturing plant in Ireland. This will be a major step in controlling our manufacturing capability in the future.
as we continue to explore other things that Rhopressa can do, we now have positive news on another potentially novel feature of the product, its ability to lower intraocular pressure at night while you're sleeping in a lying down position which normally causes intraocular pressures to climb
we did a small-scale, placebo-controlled pilot with eight subjects on Rhopressa and four on placebo. The study lasted about a week. We measured intraocular pressure for 24 hours, four of them during the night, we did 9 PM, midnight, 3 AM and 6 AM, and four time points during the day, 9, noon, 3 PM and 6 PM.
Now, in that study Rhopressa met the primary efficacy endpoint demonstrating statistically significant change from baseline to the nocturnal intraocular pressure. It reduced the nocturnal intraocular pressure by 3.5 mmHg versus placebo only 0.4 mmHg. Now, the important thing, and probably even more important, is the fact that the way that we lowered pressure at night, that nocturnal IOP lowering efficacy, was actually equal to its efficacy during the day. If that holds up in larger clinical trials, that's a big deal, that's certainly a new news that we haven't seen for any other ophthalmology product
We also have the Mercury 2 readout. Remember that's a 90-day Roclatan efficacy trial which will be the second of the two pivotals that we have for Roclatan. We'll also have the six-month Rocket 4 readout expected in Q2 of next year. So, both Mercury 2 readout and Rocket 4 the six-month readout would be in the same quarter. We'll start the Mercury 3 trial, which again is for European purposes as a comparison trial of our drug Roclatan with a known combination in Europe. That's starting in the first half of next year. And we expect to file the Roclatan NDA towards the end of 2017.
Nuevas moléculas en preclínico: 18 to 24 months to get it into the clinic
«Después de nada, o después de todo/ supe que todo no era más que nada.»
NAVB
No sé si la sigue alguien más que yo, pero aquí lo dejo. Básicamente, parece que consigue arreglar su problema de deuda y tirará para adelante.
Navidea reported total revenue for the third quarter of 2016 of $8.5 million, including Lymphoseek® (technetium Tc 99m tilmanocept) injection sales revenue of $6.7 million.
we believe that we have successfully identified an arrangement to extinguish the CRG (Capital Royalty Partners II L.P) debt and to focus Navidea on several attractive development efforts outside of lymphatic mapping, lymph node biopsy and the diagnosis of metastatic spread to lymph nodes for the staging of cancer in North America. The contemplated transaction with Cardinal Health, as well as the impending launch of Lymphoseek in Europe by our partner SpePharm AG (Norgine BV), should provide additional income for many years to come,”
Specific events and milestones achieved since the beginning of the third quarter include the following:
Operational & Financial
• Entered into Letter of Intent with Cardinal Health, Inc. for the sale of Lymphoseek in North America;
• Operating activities provided cash of $1.3 million during the first nine months of 2016, compared to $14.9 million cash used in operations during the same period in 2015;
• Reduced cash used in operations by over 100% for the first nine months of 2016 compared to the same period of 2015; and
• Appointed Michael M. Goldberg, M.D. President and Chief Executive Officer, and Eric K. Rowinsky, M.D. Chairman of the Board.
Commercial
• Achieved sequential quarter-on-quarter Lymphoseek sales revenue growth;
• Earned a $500,000 milestone payment from Cardinal Health with the sale of the 100,000th Lymphoseek dose;
• Received positive opinion in Europe for new Lymphoseek reduced-mass vial enabling a single injection per vial and triggering a $500,000 milestone payment by our partner, Norgine BV; and
• Continued to support the projected Q4 launch of Lymphoseek in Europe by Norgine BV.
Immunodiagnostic & Immunotherapeutic Development Pipeline
• Received both Institutional Review Board at University of California, San Francisco and Western Institutional Review Board approvals for a tilmanocept subcutaneous administration clinical trial protocol in rheumatoid arthritis, allowing subject enrollment to begin. To date, 17 of 18 patients have been dosed and imaged;
• Received Institutional Review Board approval for a tilmanocept clinical trial protocol in Kaposi Sarcoma which is supported by an NIH grant;
• Clinical trial results of tilmanocept in cardiovascular disease from Massachusetts General Hospital have been submitted for publication; and
• Completed a number of additional preclinical animal studies and initiated additional studies with the MT 1000 and MT 2000 class of compounds.
«Después de nada, o después de todo/ supe que todo no era más que nada.»
si no te dejan farmas siempre te quedará el cacao
en radar por la caída que lleva hay dos CHOC y NIB la segunda es más liquida.
si alguien conoce otra herramienta que lo comente.