Re: Chicharros USA - bolsa internacional
Hola!
Yo no he visto ninguno caer repentianamente desde tan alto a tan bajo. Recientemente sí varios delists a otc:
CBR
q desde 0,30 a 0,02 . Dejé de seguirlas pensando que ya intocable. Ahora que reviso están a 0,11 ( llegaron a 0,15 el pasado viernes), nada ma.l!.
TPLM
q de 0,28's a 0,05 que ahí siguen, o FALC compre a 0,36 vendi a 0,45 creo y anunciron delist, aún no se ha hecho fectivo está a 0,25.
CYTR
Revisando el ultimo 10q tema opciones, me parece entender que aún quedan unos 12 millones a media 2,85 a 7 años? 1,330,704 de ellas a 0,44 podría haber sido la bajada a 43 de la última semana?
At March 31, 2017 and December 31, 2016, there were warrants outstanding to purchase 32,394,217 and 32,502,790 shares, respectively, at a weighted-average exercise price of $0.68 in each period.
-On December 2016, the
Company granted to Steven Kriegsman, Chief Executive Officer, 2,325,581 shares of restricted common stock, pursuant to the 2008 Plan. This restricted stock vests in equal annual instalments over three years.
¿En el caso que subiera, quedaría aún bastante pastel que repartir? Sin incluir algun posible offering más, que puede elevar la flota a niveles muy chicharros cosa que con un r/s se arregla
CYTR Leyendo lo siguiente parece que son positivos, que enviaran un nda a fda a finales 2017 para farmacos basados en otro ya aprovado fda por lo que confian en una respuesta favorable y uqe de ser asi prevén el lanzamiento de aldoxorubicin EN usa 2018, que quieren enviar otro a la EMA europea.. hablan también de lo qe incluiría la etiqueta y de un laboratorio en alemania., es narrativa pump y otros fiascos fase 3 también escribían así?
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Based upon the results of the Phase 3 trial, we were granted a Type C advice meeting with the FDA on March 22, 2017 to discuss the regulatory path forward for aldoxorubicin. On April 19, 2017, we announced that we intend to submit a rolling Section 505(b)(2) NDA in the last quarter of 2017. A Section 505(b)(2) NDA is for drugs for which one or more of the investigations relied on by the applicant for approval of the application were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted. The investigations must have been performed for a drug that had received FDA approval, which in our case is doxorubicin. Doxorubicin is considered to be a reference drug, since it is the active moiety in aldoxorubicin. A Section 502(b)(2) NDA differs from a typical Section 505(b)(1) NDA in that we can rely, in part, upon the FDA's findings of safety and/or effectiveness for the reference drug, doxorubicin, provided that bridging data establishing the comparability of aldoxorubicin to doxorubicin will be deemed acceptable by FDA. Since we intend to pursue the Section 502(b)(2) regulatory pathway, our former special protocol assessment, or SPA, with the FDA is no longer applicable. We do not believe the 505(b)(2) pathway will adversely impact our Orphan Drug Designation for STS or that additional clinical studies will need to be conducted to submit our NDA. Subject to FDA approval, the commercial launch of aldoxorubicin in the United States is projected for 2018.
We also plan to discuss with the EMA a path to filing a Marketing Authorization Application, or MAA. (europa)
We are currently evaluating
aldoxorubicin in a global Phase 2b clinical trial in second-line small cell lung cancer in which we currently
expect to announce top-line data in the second quarter of 2017
The proposed aldoxorubicin product label would include "indicated for the treatment of STS." New data might allow for future use of aldoxorubicin in neoadjuvant (pre-surgery) settings, as well as a replacement for doxorubicin in combinations. We also are considering a market expansion strategy which could include other indications or formulations, including combinations of aldoxorubicin with other chemotherapeutics and immunotherapies.
We also are engaged at our laboratory facility in Freiburg, Germany in preclinical development in a new class of oncology candidates utilizing our LADR technology to attach ultra-high potency drugs to albumin (10-1,000 times more potent than traditional chemotherapies; these drugs are attached only to antibodies as antibody-drug conjugates) to target tumors.
