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CYTR
La FDA tarda un poco en la aprobacion de los medicamentos
Si la FDA considera que es prioritario tarda entre 6 y 7 meses en aprobarlo.
Si el medicamento es estandar viene tardando entre 12 y 14 meses.
Considerando que CYTR solicitó la aprobacion el 19/04/2017 todavia hasta noviembre o diciembre (si es prioritario) no se sabrá nada
IRPF
Buf, 1500 movimientos!!!, yo tengo unos 300 y me quejo.
No es así, te cuento.
- En la Web de Bankinter pides la información fiscal y te da varios listados en papel solo. El de operaciones de valores mobiliarios sí te muestra compras y ventas pero son errónes porque no coinciden con los importes de la cuenta de efectivo (la cuenta corriente donde tienes los recibos, nómina y todo lo demás).
- Seguramente que estos importes sean falsos porque hacen mal las conversiones en dólares que comentas y ya tienes supercontrastado.
Lo que hago yo:
Con una consulta de todos los movimeintos del año la paso a excel y filtro sólo las operaciones de bolsa (quito recibos, nómina si tienes, y todo lo demás). Entonces te quedan los movimientos reales que debes de tener en cuenta para la declaración de la renta, sin tener que hacer el cambio de divisa. Es mucho más rápido, y sólo tienes que unir las ventas con las compras, FIFO si son ventas parciales, etc,....
(Hubiera sido más sencillo si Bankinter diera los datos correctos)
CYTR
No, si yo no confío en que les aprueben nada, yo voy al calentón de lo que ellos llaman "conferencia", que lo más seguro es que suelten una charla insustancial, y que sus avances sean una mierda pinchá en un palo. Yo voy al calentón de la conferencia, nada más.
Hace tiempo ya, en el hilo de Farmas, habíamos unos cuantos entusiasmados con una fase-3, y en cuanto Framus nos puso los porcentajes de medicamentos que pasaban una fase-3, se nos quitaron las ganas de quedarnos dentro pero rapidito.
Vamos, que en la vida me voy a quedar dentro para una fase-3, ni de coña, por mucho alboroto que se arme con mergers, BO's, y la fiesta habitual en los foros; que luego la cagan, y el -80% no te lo quita nadie si se trata de una F-3.
"Buf, se me está haciendo más largo que un dia sin bolsa"
IRPF
Otra cosa, como dices, en el listado de Hacienda vienen los datos mal porque son los que Bankinter les ha enviado, y sólo están las ventas.
Jod !!!! miro la bolsa y cada vez más rojo.....
SSH
Parece que quuiere despertar......
Aquí un resumen de CYTR, creo que FEDE ya puso uno más sintetizado hace unas semanas, en milestones abajo dice lo que presentaran en el ASCO, por lo que entiendo estan probando en varias fases distintas el aldorubi..
CytRx Reports First Quarter 2017 Financial Results
LOS ANGELES, May 10, 2017 /PRNewswire/ -- CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced financial results for the quarter ended March 31, 2017, and provided an overview of recent accomplishments and upcoming milestones for its research and development programs.
"To date, 2017 has been marked by several key achievements, but most importantly, by obtaining clarity from the U.S. Food and Drug Administration (FDA) regarding our soft tissue sarcomas (STS) program and the establishment of a definitive regulatory path toward approval for aldoxorubicin as a treatment for patients with this rare, difficult to treat disease," said Steven A. Kriegsman, CytRx's Chairman and CEO. "Our Phase 3 trial investigating aldoxorubicin in patients with second-line STS concluded and the data will be used to support our filing strategy."
"Finally, we look forward to presenting the more detailed and updated global Phase 3 STS results to the medical community at the upcoming 2017 American Society of Clinical Oncology (ASCO) Annual Meeting. This Phase 3 trial, along with the combination trial of aldoxorubicin with ifosfamide/mesna, continue to build upon the body of clinical data supporting aldoxorubicin's potential as a new and better treatment for patients with STS," Mr. Kriegsman commented.
First Quarter 2017 and Recent Highlights
Strengthened the Balance Sheet with $15 Million in Financing and $2 Million in Warrant Proceeds. In early May 2017, CytRx completed the sale of approximately 30 million shares of common stock in a public offering at a price of $0.50 per share, resulting in net proceeds to the Company of approximately $13.9 million after deducting placement agent's fees and other estimated offering expenses. Additionally, the Company received approximately $1.9 million from the exercise of warrants resulting in a total raise of $15.8 million subsequent to March 31, 2017.
Concluded Phase 3 Trial Evaluating Aldoxorubicin in Relapsed or Refractory STS. Based on its goal to submit a rolling NDA, subject to approval from the FDA, the Company has concluded its Phase 3 study evaluating aldoxorubicin compared to investigator's choice in patients with relapsed or refractory STS.
Aldoxorubicin Clinical Trial Data in Patients with STS Selected for Oral Presentation at the 2017 American Society of Clinical Oncology Annual Meeting (ASCO). In April 2017, CytRx announced that an abstract describing results from its global Phase 3 clinical trial evaluating aldoxorubicin versus investigators' choice in patients with relapsed and refractory STS was selected for an oral presentation at ASCO 2017, taking place June 2-6, 2017 in Chicago. The oral presentation (abstract #11000) will be given by Principal Investigator, Sant Chawla, M.D., F.R.A.C.P., Director of the Sarcoma Oncology Center in Santa Monica, on Friday, June 2, 2017 between 3:00-6:00 pm CT. In addition to the STS presentation, a poster (abstract #11051) highlighting updated data from CytRx's ongoing Phase 1/2 clinical trial combining aldoxorubicin with ifosfamide/mesna in patients with first-line soft tissue sarcomas will also be presented by Frederick C. Eilber, M.D., Director of the UCLA Sarcoma Translational Research Program within the Jonsson Comprehensive Cancer Center, on Sunday, June 4, 2017 between 8:00-11:00 am CT.
Announced FDA Agreement on Regulatory Pathway to Approval for Aldoxorubicin in STS. In April 2017, CytRx announced that it had reached an agreement with the FDA on the pathway for a NDA submission for aldoxorubicin as a treatment for STS. The Company's goal is to submit a rolling NDA under section 505(b)(2) to the FDA in the fourth quarter of 2017. The commercial launch of aldoxorubicin is projected for 2018 in the U.S. Aldoxorubicin has received Orphan Drug Designation from the FDA for the treatment of STS, which provides for several benefits including seven years of market exclusivity after approval, certain R&D related tax credits and protocol assistance from the FDA. CytRx also plans to discuss with the European Medicines Agency a path to filing a Marketing Authorization Application. European regulators granted aldoxorubicin Orphan Medicinal Product Designation for STS which confers ten years of market exclusivity among other benefits.
Upcoming Milestones
First Quarter 2017 Financial Results
CytRx reported cash, cash equivalents and short-term investments of $48.0 million as of March 31, 2017.
On May 2, 2017, CytRx completed a public offering of 30 million shares of its common stock at a price of $0.50 per share. The net proceeds to CytRx from the offering, after deducting placement agent's fees and other estimated offering expenses, were approximately $13.9 million. In addition, CytRx received $1.9 million in proceeds from the exercise of warrants in April and May 2017.
Net loss for the quarter ended March 31, 2017, was $11.0 million, or $(0.10) per share, compared with a net loss of $12.6 million, or $(0.19) per share, for the quarter ended March 31, 2016. During the first quarter of 2017, the Company recognized a non-cash loss of $0.03 million on the fair value adjustment of warrant derivative liability related to warrants issued in 2016, compared to a non-cash loss of $0.2 million during the first quarter of 2016 related to now expired warrants.
Research and development (R&D) expenses were $6.8 million for the first quarter of 2017, and included development expenses of $4.0 million for aldoxorubicin, approximately $0.6 million for pre-clinical development of new albumin-binding, ultra-high potency cancer drugs (German lab), and approximately $2.2 million for general operation of our clinical programs. R&D expenses were $8.2 million for the first quarter of 2016.
General and administrative (G&A) expenses were $3.0 million for the first quarter of 2017, compared with $4.0 million for the first quarter of 2016.
SSH
Calma, calma, enseguida se nos ponen rojas; a ver si vamos a romper esa preciosa gama cromática de tonos rojos con un asqueroso verde.
"Buf, se me está haciendo más largo que un dia sin bolsa"
CYTR
Joer, amplía la info en español, ¿son buenos?, cuenta.. cuenta..
"Buf, se me está haciendo más largo que un dia sin bolsa"
CYTR
Jajajaja. te lo he leido y me estoy partiendo de cómo lo has dicho. Tienes toda la razón, yo tambien pienso así, las historias son cuentos baratos para intentar ganar los dineros a los mismos, que somos nosotros, las manos débiles. Siempre tenemos que desconfiar.
Todo se hace por intereses ocultos, y como los desconocemos, mejor es aislarlos y no hacerlos caso....