Farmas USA

La doblaré. No te puedo decir mas que eso. ;)

NVAX

De lo que este pasando ahora ... bueno, todavia no ha roto nada ... de momento ...

Ayer comenté que me parecia claro que se fuera a tapar hueco

( velas 5 min )

Muchas gracias.

Cuando haya alguna farma rondando el triple cero avisaré por aquí, meten unos arreones tremendos: ENTB, BMSN, ATRN, BIEL (esta última es de equipos médicos más bien)

Se pueden marcar un 1000 % en cosa de dos semanas, pero acarrean un riesgo muy importante también, por supuesto.

http://www.fiercepharma.com/story/mystery-investment-fund-eyes-640m-bid-struggling-obesity-drug-maker-vivus/2014-05-29?utm_source=share&utm_medium=app&utm_campaign=Share

Hoy seguimos la rima y repetimos el verde pero Lunes y Martes recogida de beneficios, para los que gustan del corto plazo,,,, Siga la rima que la tendencia es tu amiga

http://finance.yahoo.com/news/asian-shares-higher-early-trade-002718439.html

Carta del CEO /ACTC a sus shareholders
--http://www.sec.gov/Archives/edgar/data/883975/000129993314000865/exhibit1.htm
,,,,,
DVAX
Anual Meeting, autoriza el RS a futuro sin fecha prevista y Stock Options por un tubo para su directiva,
Esto. me huele a fuerte run up en el medio plazo si hacen lo que ahora es un rumor, presentar HEPLISAV para su aprobación a un grupo reducido de pacientes día béticos que es el estudio más avanzado para después presentar los otros grupos pero con el RS el precio se irá por encima de 5 y si la FDA le da el sí que es muy probable, esta se irá por encima de 10 y a eso niveles poco retail entra pero a todo RS a eso niveles le sigue una dilucion, pero estamos hablando de un plazo de meses
http://investors.dynavax.com/sec.cfm

AMRN

Parece que se mueve ficha con la cancelacion del SPA. Es un primer paso, los usanos estan emocionados:

Special Protocol Assessment Agreements.—The Committee is concerned about questions that have arisen in connection with the rescission of a Special Protocol Assessment Agreement (SPA), including fundamental questions concerning FDA’s adherence to the statutory and regulatory guidelines that apply to the SPA process as well as to questions concerning fairness to the sponsors. The Committee would like to reiterate that FDA is expected to adhere to the established standard as informed by the Congressional Record and the 1997 PDUFA Goals Letter
.
The Committee is aware of FDA’s ability to rescind a SPA agreement reached under section 505(b)(5)(C)(ii) of the Food, Drug, and Cosmetic Act only if it demonstrates that ‘‘a substantial scientific issue essential to determining the safety or efficacy of the product has been identified after the testing has begun.’’
This standard is informed by the Congressional Record and the 1997 PDUFA Goals Letter. The Congressional report explains that Congress intended ‘‘that such agreements should be binding on both parties’’ except when ‘‘a substantial scientific issue has come to light after an agreement has been reached and testing has begun, which has a direct bearing on the safety or effectiveness of the product.’’
The Committee also expects that, as a matter of public policy and fundamental fairness to the sponsor, FDA should be accountable for continued diligence in identifying issues that bear on the continued enforceability of a SPA agreement and in notifying the sponsor of such issues within a reasonable period of time after FDA becomes aware.
To ensure agreement over the standard to rescind a SPA, the Committee directs FDA to report to the Committees on Appropriations of the House and Senate within 60 days of enactment of this Act regarding the standard by which FDA would rescind a SPA. Lastly, to ensure agreement over the standard to rescind a SPA, the Committee directs FDA to revise and re-issue, after public comment, its existing guidance regarding SPA agreements to clarify the agency’s interpretation of the statutory standard regarding SPA agreements and the rescission of such agreements. (Additional background here
.)

http://www.fdalawblog.net/

NVAX

Otra opción podría ser ésta:

La carta no es del CEO de ACTC sino del CEO de STEM.

De acuerdo en lo de DVAX, tiene pinta de subir, quizás venga antes el subidón que el RS.