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Pharmacyclics - PCYC

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[verwijderd] 21 februari 2007 15:53

-48% Van 5.04 naar 2.58

Pharmacyclics Receives Refuse to File Letter for Xcytrin
Wednesday February 21, 7:30 am ET
Conference Call at 9:00 AM Eastern Time

SUNNYVALE, Calif., Feb. 21 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - News) today announced that it has received a refuse to file letter from the U.S. Food and Drug Administration (FDA) for the company's new drug application (NDA) for Xcytrin® (motexafin gadolinium) Injection for the treatment of non-small cell lung cancer patients with brain metastases.
In the letter, the FDA stated that the company's application is not sufficiently complete to permit a substantive review based on clinical studies that failed to demonstrate statistically significant differences between treatment arms in the primary endpoints.

"We will be evaluating our options with Xcytrin for the brain metastases indication and determine the best path forward," said Richard A. Miller, M.D., president and CEO of Pharmacyclics. "Beyond this indication, the clinical development program with Xcytrin continues on multiple fronts. Several ongoing trials are evaluating Xcytrin in non-small cell lung cancer and other cancers. We are also moving forward with several other novel compounds, which are in clinical and preclinical development."

biz.yahoo.com/prnews/070221/sfw046.ht...

[verwijderd] 21 februari 2007 20:06

Al redelijk bijgetrokken RT 3.32 Nog -34% t.o.v. gisteren, maar al 32% gestegen t.o.v. de opening vandaag.

[verwijderd] 26 februari 2007 22:39

Goed moment om in te stappen na zo'n afstraffing. Kan alleen nog maar omhoog gaan zou je denken.

Eigenaar heeft paar dagen geleden heel flink ingekocht.

Heb zelf gekocht op $3.15.
Succes!

[verwijderd] 4 april 2007 17:20

Kan interessant worden.
Kans alsnog goedkeuring zoals bij DNDN enorm toegenomen

inmiddels bekend dat expert pannel hun goedkeuring gaat adviseren.. FDA zal toch onder druk komen staan zo

Pharmacyclics' Xcytrin New Drug Application for Treatment of Lung Cancer Brain Metastases to Be Filed Over Protest
Wednesday April 4, 8:00 am ET

SUNNYVALE, Calif., April 4 /PRNewswire-FirstCall/ -- Pharmacyclics, Inc. (Nasdaq: PCYC - News) today announced its request to the U.S. Food and Drug Administration (FDA) that its New Drug Application (NDA) for Xcytrin® (motexafin gadolinium) Injection be filed over protest. The NDA seeks approval to market the drug for the treatment of non-small cell lung cancer (NSCLC) patients with brain metastases (i.e., cancer that has spread to the brain from another part of the body).

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In December 2006, the Company submitted an NDA to the FDA's Division of Drug Oncology Products requesting marketing clearance for Xcytrin in combination with radiation therapy for the treatment of brain metastases from NSCLC. In February 2007, it received a refuse to file letter from the FDA citing failure to demonstrate statistically significant differences between treatment arms in the primary endpoint of the pivotal study to support approval.

File over protest is a procedure permitted by regulation, which allows sponsors to have their NDA filed and reviewed when there is disagreement over the acceptability of the NDA.

Pharmacyclics is taking this action to ensure that its NDA receives a complete review. According to the regulations, the filing date will be on or about April 30, 2007, which is 60 days after the company requested a meeting to discuss the refuse to file letter. FDA has either four or eight months to review the NDA depending on whether it designates the filing for Priority or Standard review. There can be no assurance that the NDA will be approved or that there will be an advisory panel meeting to review the data.

"We strongly believe that the clinical data justify a complete and thorough review and that a panel of experts be given an opportunity to examine and evaluate the data," said Richard A. Miller, M.D., president and CEO of Pharmacyclics. "We owe it to patients suffering from brain metastases from non-small cell lung cancer, a devastating and debilitating disease for which there are limited treatment options, to proceed with every reasonable effort to make this drug available. We are eager to work with the FDA to complete the review of our NDA."

According to the National Cancer Institute, over 200,000 patients will be diagnosed with lung cancer this year in the U.S. Lung cancer is the most common cause of brain metastases, which are estimated to occur in up to 50% of lung cancer patients. Spread of lung cancer to the brain may occur early in the course of disease or may be a late complication of this illness. This is a disease that causes devastating and deadly neurologic problems and is increasing in incidence.

No drug or treatment has ever been shown to provide neurologic benefit to these patients.

Brain metastases occur when cancer cells spread to the brain and grow, causing major neurologic complications. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as paralysis, loss of vision, disturbances of gait and speech, decrease in mental status, loss of short-term memory, compromised verbal skills and reduction in cognitive ability. Standard therapy for patients with brain metastases from lung cancer involves the prompt use of cranial radiation, which is used to prevent neurological deterioration and improve neurologic outcomes.

"After consultation with investigators, experts and patient groups, we decided to have our NDA filed over protest because there are other examples of NDAs for oncology drugs that have been accepted for filing without meeting the primary endpoint with statistical significance. In some cases this has led to product approvals, particularly in cases where the unmet need is great, the drug is well tolerated and there are few if any other treatment options available," added Dr. Miller. "We collectively believe that it is in the best interests of patients to do everything we can to make this drug available for treatment of this horrible condition."

The NDA submission was based on the results of two randomized trials and an integrated analysis of both trials. These trials utilized an innovative neurologic progression endpoint designed with FDA to assess the clinical benefit of treatment. The first of these trials, which included 251 NSCLC patients and 150 patients with brain metastases from other solid tumors, showed a clinically and statistically significant improvement in time to neurologic progression in patients with NSCLC.

The follow up pivotal 554-patient SMART trial showed a 5.4 month improvement in time to neurologic progression, the primary pre-specified endpoint, with a median time to neurologic progression of 15.4 months for Xcytrin compared to 10.0 months for the control (with a p-value equal to 0.12). While not statistically significant, this represented a very strong and promising treatment effect in a disease for which nothing has worked beyond radiation therapy.

An integrated analysis of the 805 lung cancer patients in these two large Phase 3 studies demonstrated a statistically significant 6.4 month improvement in time to neurologic progression for patients receiving Xcytrin plus whole brain radiation therapy compared to those receiving radiation alone. The median time to neurologic progression was 15.4 months compared to 9.0 months, respectively, with a p-value equal to 0.016. Secondary endpoints also showed a significant benefit for Xcytrin plus whole brain radiation compared to radiation alone: time to neurologic progression as determined by investigators, P = 0.015 and time to neurocognitive progression, P = 0.02. In addition to this consistent treatment effect, Xcytrin plus radiation therapy was generally well tolerated across all studies.

Conference Call Details

Pharmacyclics will hold a conference call today at 9:00 a.m. EDT to discuss this announcement. To participate in the conference call, please dial 800-497-0451 for domestic callers and 706-758-3306 for international callers and reference conference passcode, 4767727. To access the live audio broadcast or the subsequent archived recording, log on to ir.pharmacyclics.com. The archived version of the webcast will be available on the company's website for one month.

About Xcytrin

Pharmacyclics is developing Xcytrin as an anti-cancer agent with a novel mechanism of action that is designed to selectively concentrate in tumors and induce apoptosis (programmed cell death). Xcytrin is a redox-active drug that has been shown to disrupt redox-dependent pathways in cells and inhibit oxidative stress related proteins. Its multifunctional mode of action provides the opportunity for Xcytrin to be used in a broad range of cancers.

About Pharmacyclics

Pharmacyclics is a pharmaceutical company developing innovative products to treat cancer and other serious diseases. The company is leveraging its small-molecule drug development expertise to build a pipeline in oncology and other diseases based on a wide range of targets, pathways and mechanisms. Its lead product, Xcytrin®, has completed Phase 3 clinical trials and

[verwijderd] 12 april 2007 09:22

Ik volg nu met interesse de 'case' Dendreon/Pharmacyclics (PCYC). In de laatste heb ik ook, nadat zij de 'refuse to file letter' van de FDA (mbt Xcytrin) hebben ontvangen, een positie ingenomen.

Een week nadat de FDA's Office of Cellular, Tissue and Gene Therapies Advisory Committee Provenge heeft aanbevolen heeft PCYC protest tegen hun refuse to file letter aangetekend.
Hoewel beide medicijnen niet helemaal met elkaar zijn te vergelijken, zijn wel de resultaten vanuit beider onderzoeken vergelijkbaar. De vraag is: waarom wordt Provenge wel aanbevolen en Xcytrin niet.

Een interessante case dus.

- wordt Xcytrin alsnog aanbevolen, mede vanwege aanbeveling Provenge? Dan kun je een koersexplosie van PCYC verwachten!
- krijgt DNDN een approvable letter voor Provenge in plaats van een approval? Dan kan de koers van DNDN behoorlijk in elkaar zakken.
- krijgt DNDN wel een approval en PCYC niet? Dan is het laatste woord daar nog niet over gezegd.

Ook het tijdspad wordt zeer interesant.
Wie krijgt het eerst wat te horen van de FDA?
Wat voor gevolgen heeft dat voor de ander?

Kortom, leuk om in de gaten te houden en daarop te speculeren.

[verwijderd] 9 mei 2007 23:06

"The tiny biotechnology company last month took the unusual step of filing its application for the vaccine Xcytrin over protest, in effect forcing the Food and Drug Administration to review it for approval despite the FDA refusal"

Pharmacyclics CEO confident of Xcytrin approval

NEW YORK, May 9 (Reuters) - Pharmacyclics Inc. (PCYC.O: Quote, Profile , Research) Chief Executive Richard Miller on Wednesday expressed confidence that the company's experimental cancer vaccine will win U.S. approval despite initial rejection of the new drug application by U.S. health regulators.

The tiny biotechnology company last month took the unusual step of filing its application for the vaccine Xcytrin over protest, in effect forcing the Food and Drug Administration to review it for approval despite the FDA refusal based on the drug's failure to meet a prespecified primary goal in a pivotal late stage clinical trial of patients with lung cancer that had spread to the brain.

"I'm convinced we'll get Xcytrin approved eventually for something because I believe it's an active drug," Miller said in an interview.

"I think our data shows substantial efficacy and I think if they review it in detail and put it in proper context, bringing in advisors who know the disease, that it should meet that standard" (for approval), Miller said.

With some 100,000 cases of brain metastases from lung cancer diagnosed in the United States each year, and few if any treatment options available that address the cognitive and physical impairments caused by the disease, Miller said Xcytrin could become a hugely successful product.

"I believe it would become the standard of care," he said. "There's no other treatment, so why wouldn't a doctor use this? If people look at the data in detail, they'll want to use this drug."

tinyurl.com/2edb6e

[verwijderd] 15 mei 2007 22:40

zie finance.yahoo.com.
major holders.
de eerste figuur op die lijst robert dugham, klik aan en zie wat daar staat. wie begrijpt dat en kan dat uitleggen.

deze persoon koopt steeds groot in op 3 en 4 dollar en verkoopt op 94 tot 103 dollar
voor miljoenen. wat heeft dat te betekenen?

iemand?

[verwijderd] 20 december 2007 20:36

In gaten houden de komende maanden.
Zal meeliften met DNDN nieuws.

Zit al maanden op deze bodem te koersen.
Lager kan bijna niet.

Als Xcytrin alsnog approval krijgt, moet je eens opletten.
Dan gaat ie zo richting de $10.

[verwijderd] 20 december 2007 20:39

quote:
ohmygod schreef:
Lager kan bijna niet....

Kan nog 2,33 af hoor,dat is 100% van uw inleg !

[verwijderd] 24 december 2007 15:14

finance.yahoo.com/mp#pcyc Lekkere tip van meneer Ohmygod..""lager kan bijna niet"" riep ie vorige week,stort helemaal in voorbeurs !

[verwijderd] 24 december 2007 15:15

quote:
ohmygod schreef:
In gaten houden de komende maanden.
Zal meeliften met DNDN nieuws.

Zit al maanden op deze bodem te koersen.
Lager kan bijna niet.

Als Xcytrin alsnog approval krijgt, moet je eens opletten.
Dan gaat ie zo richting de $10.

8:09AM Pharmacyclics announced on Friday after the close that it receives a non-approvable letter from the FDA for Xcytrin for the treatment of lung cancer brain metastases (PCYC) 2.36 : Co announced on Friday after the close that it has received a non-approvable letter from the FDA for the co's new drug application for Xcytrin Injection for the treatment of non-small cell lung cancer patients with brain metastases. "We are disappointed that brain metastases patients with limited options and serious neurologic problems will not have access to Xcytrin, which we believe has shown important clinical activity in this indication," said Richard Miller, president and CEO.

[verwijderd] 24 december 2007 15:46

quote:
ohmygod schreef:
In gaten houden de komende maanden.
Zal meeliften met DNDN nieuws.

Zit al maanden op deze bodem te koersen.
Lager kan bijna niet.

Als Xcytrin alsnog approval krijgt, moet je eens opletten.
Dan gaat ie zo richting de $10.

Oh mijn god...krijgt flink ervan langs,stort compleet in....wat ""op deze bodem""???

[verwijderd] 24 december 2007 19:19

PHARMACYCLICS INC (NasdaqGM:PCYC)

Last Trade: 1.74
Trade Time: 1:00PM ET
Change: -0.62 (-26.27%)

Daylow ! bloedbad !

Henk Snaph 24 december 2007 19:28

quote:
Ziener. schreef:
PHARMACYCLICS INC (NasdaqGM:PCYC)

Last Trade: 1.74
Trade Time: 1:00PM ET
Change: -0.62 (-26.27%)

Daylow ! bloedbad !

Eenvoudig in één woord mijn kommentaar, hoe ook de IEX regageert, want daarvoor heb ik helemaal geen respekt meer: Jij bent de grootste klootzak die er rondloop en de IEX is géén haar beter. Vroeger hadden ten minste noch iemand die ingreep, dat kunnen we nu gewoon vergeten. Ik weet dat ik hiemee riskeer eruit gegooid te worden maar dat risiko neem ik en ik ben graag bereid hievoor kosten voor een advokaat op nemen. Ik wens iedereen met uitzondering van de forum-moderator hele fijne
kerstdagen.

Henks

[verwijderd] 24 december 2007 19:31

Henks, zijn we het, zo voor de kerst, toch eens een keer met elkaar eens.

Ook goede dagen gewenst, ook de rest of the crew.

Psycho

Henk Snaph 24 december 2007 20:00

quote:
psycho-pharma schreef:
Henks, zijn we het, zo voor de kerst, toch eens een keer met elkaar eens.

Ook goede dagen gewenst, ook de rest of the crew.

Psycho

Thanks psycho, en ook fijne dagen toegewenst

Henks

[verwijderd] 24 december 2007 20:06

quote:
Henk Snaph schreef:
[quote=psycho-pharma]
Henks, zijn we het, zo voor de kerst, toch eens een keer met elkaar eens.

Ook goede dagen gewenst, ook de rest of the crew.

Psycho
[/quote]

Thanks psycho, en ook fijne dagen toegewenst

Henks

Jullie ook,tot woensdag 15:30!

[verwijderd] 24 december 2007 21:28

quote:
Trader nr1. schreef:
[quote=Henk Snaph]
[quote=psycho-pharma]
Henks, zijn we het, zo voor de kerst, toch eens een keer met elkaar eens.

Ook goede dagen gewenst, ook de rest of the crew.

Psycho
[/quote]

Thanks psycho, en ook fijne dagen toegewenst

Henks
[/quote]Jullie ook,tot woensdag 15:30!

Nou trader nr1. alias easymoney/lucht/zitnooitfout/ziener maar vooral superprutser: heb je tenminste 2 eneenhalve dag de tijd om een nieuw alias te bedenken... Ik hoop dat je in je kippebout stikt (zo, ook een risico om eruit gegooid te worden, dan hebben we tenminste de aandacht).

Voor iedereen anders: fijne dagen !!

Ries

[verwijderd] 24 december 2007 21:47

quote:
Rieltijm schreef:
heb je tenminste 2 eneenhalve dag de tijd om een nieuw alias te bedenken...

Nee 1,5 dag,woensdag om 15:30 is de VS. weer al open een gehele dag.

[verwijderd] 24 december 2007 22:51

quote:
SkySpam1 schreef:
andere verplichtingen roepen nu,

Ben nog steeds benieuwd wat ie nou moest gaan doen,....verplichtingen??

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