Farmas USA

vale, te he respondido que "si" a lo del ADCOM por lo del ADvisor COMmitte . Pero tienes razon

http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/OncologicDrugsAdvisoryCommittee/

Siete soles, desde mi ignorancia, cuando voto la FDA en contra del comité de expertos en ZGNX?

Hablo de cabeza y lo mismo me equivoco pero creo recordar que en el ADCOM previo a la aprobación de Zohydro los expertos votaron que no, y en la PDFUA la FDA voto que si. Se me quedó porque no es muy habitual que pase así.

ZGNX

Lo he encontrado, fue el 11-2-2013 y el resultado fue 11-2 en contra!!!

ZGNX: AdComm Said No To Zohydro ER, But FDA May Not Listen

• Summary: FDA AdComm voted against approval of Zohydro ER, but FDA decision (PDUFA: 3/1/2013) could be different, in our view. The vote was more reflective of dissatisfaction of the drug class and its current REMS, and we are unsure if FDA will single out hydrocodone by imposing more stringent requirements. We continue to believe an approval is a probable outcome, but cannot rule out a modest (several months) delay. We would buy on weakness resulting from the "negative" vote.

• AdComm voted 2-11 against approval of Zohydro ER. On the surface, the panel appeared overwhelmingly negative, but we believe the direction of the vote reflects dissatisfaction of the entire class (extended-release C-II opioids) rather than with Zohydro ER itself. The panel was uncertain about the robustness of the class-wide REMS program. Specific to Zohydro ER, the panel was concerned about the lack of tamper-resistance characteristics in the formulation under review. Zohydro ER is an extended release hydrocodone for the management of moderate to severe chronic pain. The PDUFA date is 3/1/2013.

• FDA has a dilemma. The main complication for FDA is that it has to view Zohydro ER in the context of the entire class of extended release C-II opioids, and at several instances encouraged the panel to highlight any Zohydro ER-specific differences over the class. So should FDA single out hydrocodone by requiring longer-term studies to #$%$ safety/efficacy and a more stringent REMS program? Also, will FDA require tamper-resistance to be incorporated into Zohydro ER when there is no labeling for tamper-resistance? And what happens to the other non-tamper-resistant C-II opioids that are on the market now?

• Approval is still a probable outcome, in our view. Our reasoning is based on FDA's acknowledgement that Zohydro ER is effective and safe when used as intended. At the same time we do not believe FDA will require a more stringent REMS program for Zohydro ER, other than incorporating the voluntary measures proposed by ZGNX. Of course, we cannot predict FDA action with certainty, and FDA could extend the review period to buy itself more time.

• The major risk to our position is requirement of tamper-resistance in the Zohydro formulation. By ZGNX's admission, its tamper-resistance formulation is several years away, so such a requirement would result in a multiyear delay. However, such requirement would run counter to the fact that FDA has not allowed tamper-resistant claims in the label of approved opioids.

Valuation Range: $3.50 to $4.00

We derive our valuation range by applying a P/E multiple of 13.0-14.0x our 2015E EPS of $0.35, discounted back for two years at 14.8% per year. Risks to the stock trading to our valuation range include regulatory setback for Zohydro ER and deceleration in Sumavel DosePro Rx growth.

Investment Thesis:

We like the value proposition of Sumavel DosePro and Zohydro ER. We believe management's ability to hit financial guidance, grow Sumavel DosePro, and advance Zohydro ER are potential catalysts.

Off-topic

Tengo una duda que no acabo de entender. Estoy viendo que UGAZ baja un 10% mientras GASL sube un 1% y ambas son bull x3. Eso se explica solamente porque UGAZ es un ETN y GASL un ETF o me pierdo algo más?

Es que me parece mucha diferencia.

Gracias eso si, también esta el tema político, pero la FDA esta mas a favor del valor terapéutico.
Espero que el 30 dé enero la PDFUA sea positiva y vuelva a esos niveles dé 3$

No lo tengo claro pero creo que UGAZ es un ETN referenciado al precio de la materia prima y GASL es un ETF referenciado a acciones de empresas relacionadas con el gas, pero no estoy seguro

Gracias, sí, eso es lo que había leído, pero desconozco si ese puede ser el motivo de que una reacciona mucho más que la otra (y en este caso, en sentido contrario):

"Una de las diferencias que tiene este producto respecto de los ETFs es que mientras la cartera de un ETF está compuesta por los componentes del índice, la cartera de un ETN está compuesta por bonos y opciones que replican al subyacente en tiempo real."

Bueno, las UGAZ parecen cerca de hacer un doble suelo en 10 bajos, puede ser buen momento para entrar (si me atrevo!).