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HIV; waarom lager?

1.470 Posts, Pagina: « 1 2 3 4 5 6 ... 61 62 63 64 65 66 67 68 69 70 71 72 73 74 » | Laatste
gustaaf1e
0
Echte nieuws moet nog komen. Dit is toestemming om te gaan produceren op het moment(once) dat "specific product approval is received". Die approval moet dus nog komen. (maar je kunt dit wel als een voorbode van die goedkeuring zien).
Ze maken het wel spannend.

G
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Iemand enig idee wanneer deze goedkeuring wordt verwacht? Of is ook dit koffiedikkijken?

Fox

Word er langzamerhand een beetje ongeduldig van.
gustaaf1e
0
fox,
Bij de Chinese FDA was degene die over de goedkeuring gaat een plastic groene krokodil van z'n zoontje kwijt en om die terug te krijgen moet hij eerst een formulier invullen. Dus hij is daar eerst nog ff mee bezig en daarna gaat ie weer met z'n werk verder. Vandaar dat 't ff duurt.

Overigens: zie hiervoor in een van de pb's waar staat dat ze bij Calypte ook op die goedkeuring zitten te wachten, maar natuurlijk geen concrete datum kunnen noemen.

Maar 't zal toch zo langzamerhand wel eens gaan gebeuren.
G
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Money in the bank!!
Toestemming China zal snel gebeuren, lijkt mij.

Calypte Biomedical Enters into $8.0 Million Common Stock Purchase Agreement with Fusion Capital
PORTLAND, Ore.--(BUSINESS WIRE)--Jan. 23, 2008--Calypte Biomedical Corporation (OTCBB:CBMC), a developer, manufacturer and marketer of HIV diagnostic tests, today announced it has entered into a $8.0 million common stock purchase agreement with Fusion Capital Fund II, LLC, a Chicago-based institutional investor. The Company may sell up to $8.0 million of its common stock to Fusion Capital from time to time over a 24-month period after the Securities and Exchange Commission (SEC) has declared effective the registration statement related to the transaction. The proceeds will be used to further the commercialization of the Company's Aware(TM) HIV-1/2 Rapid diagnostic tests, develop new diagnostic tests and for general corporate purposes.

Under the agreement, the Company has the right to sell shares of common stock to Fusion Capital from time to time in amounts between $100,000 and $1.0 million, depending on certain conditions, for up to $8.0 million of total funds. The purchase price of the shares will be based on the prevailing market prices of the Company's shares at the time of sale without any fixed discount, and the Company will control the timing and amount of any sales of shares to Fusion Capital. There are no negative covenants, restrictions on future financings, penalties or liquidated damages in the agreement. A more detailed description of the transaction, as well as the agreement, is set forth in the Company's Report on Form 8-K filed today with the SEC which should be reviewed carefully in conjunction with this press release.

"We are very pleased to enter into this $8.0 million funding agreement with Fusion Capital, a respected institutional fund that has been investing in technology and health care companies for over eight years," said Roger I. Gale, CEO of Calypte. "The agreement, as a complement to funding potentially available to us from other sources, provides the Company with the flexibility to help us grow our rapid HIV diagnostic testing business in large developing markets as well as in the U.S."

P.
gustaaf1e
0
Die laatste zin geeft m.i. aan dat dit geld vooral bedoeld is om de test goed in de Chinese markt te zetten.(to help us grow our ...business in large developing markets as well as in the U.S.)

Lijkt goed moment om op deze lage koers te kopen.
G
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The most important aspect regarding this agreement is imho:

The purchase price of the shares will be based on the prevailing market prices of the Company's shares at the time of sale without any fixed discount, and the Company will control the timing and amount of any sales of shares to Fusion Capital.

There are no negative covenants, restrictions on future financings, penalties or liquidated damages in the agreement.
[verwijderd]
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Chinese State FDA Completes Technical Review of Calypte Biomedical's Oral HIV Test Application
Thursday January 24, 8:00 am ET

PORTLAND, Ore.--(BUSINESS WIRE)--Calypte Biomedical Corporation (OTCBB: CBMC - News), a developer, manufacturer and marketer of HIV diagnostic tests, announced today that the Chinese State Food and Drug Administration (“SFDA”) has notified Calypte’s Chinese manufacturing subsidiary, Beijing Marr Bio-pharmaceutical Co., Ltd., (“Beijing Marr”) that the technical review of its Aware™ HIV-1/2 OMT rapid oral test product application has been completed. Pending the SFDA’s review of conformity to product standard documents and labeling to applicable regulations, the application will progress to the concluding administrative approval.
Roger I. Gale, Calypte's President and Chief Executive Officer, stated, "This is a major milestone in a long and difficult approval process. We are extremely pleased that the SFDA has determined that our scientific data has met their criteria, and that we are now moving into the final phase of the registration process. We believe that in meeting the technical standards established by the SFDA, we have demonstrated to them the high quality of our product.”

Dr. Ronald W. Mink, Calypte’s Chief Science Officer, commented, “The technical review is considered the most challenging and lengthy portion of the SFDA review process, and is the penultimate milestone in the approval process. We are absolutely delighted that we have overcome what is arguably the highest hurdle in the approval process, and are ready to move into the final administrative stage.”

David K. Harris, Beijing Marr’s Chief Executive Officer stated that, “The notice from the SFDA is of paramount importance and indicates that the substantive content of the application and the technology itself have met with the acceptance of the SFDA and are acceptable for the Chinese market. Nearing the end of an arduous approval process, we are very proud to see this recognition of years of hard work in developing the AwareTM HIV-1/2 OMT product.”

Calypte operates in China through Beijing Marr, a joint venture between Calypte and the Marr Group established to manufacture Calypte’s Aware™ line of rapid HIV tests, including the Aware™ HIV-1/2 OMT product for both the Chinese and international markets. The Aware™ HIV-1/2 OMT product is a rapid test using oral fluid to diagnose HIV-1 or HIV-2 infection in as little as 20 minutes with an accuracy comparable to that of U.S. FDA approved blood based laboratory HIV EIA tests.

biz.yahoo.com/bw/080124/2008012400529...
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Bingo!!!!!!!!

Lang gewacht, stil gezwegen, toch gekregen!!

Gefeliciteerd longs!!

Psycho
100K
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0
quote:

psycho-pharma schreef:

Bingo!!!!!!!!

Lang gewacht, stil gezwegen, toch gekregen!!

Gefeliciteerd longs!!

Psycho
100K
Ik begrijp hier uit dat dit nog geen definitieve goedkeuring is. Het onderzoek is afgerond. Wel heel merkwaardig dat eerst de koers omlaag moest om nieuw kapitaal op te halen, en daarna beginnen ze te pumpen.
[verwijderd]
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quote:

Jommeke schreef:

[quote=psycho-pharma]
Bingo!!!!!!!!

Lang gewacht, stil gezwegen, toch gekregen!!

Gefeliciteerd longs!!

Psycho
100K
[/quote]
Ik begrijp hier uit dat dit nog geen definitieve goedkeuring is. Het onderzoek is afgerond. Wel heel merkwaardig dat eerst de koers omlaag moest om nieuw kapitaal op te halen, en daarna beginnen ze te pumpen.
Wel goedkeuring, maar nog niet afgerond. Vergelijk de goedkeuring van de EMEA, die daarna pas in werking is nadat de EU de goedkeuring bekrachtigd heeft. Zo ook in China.
"“The technical review is considered the most challenging and lengthy portion of the SFDA review process, and is the penultimate milestone in the approval process. We are absolutely delighted that we have overcome what is arguably the highest hurdle in the approval process, and are ready to move into the final administrative stage.”

P.
[verwijderd]
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Longs, als je op zijn snelst de nieuwtjes van Calypte wilt weten, doe even een mailtje naar Dan:

Investor Relations:
CEOcast, Inc.
Dan Schustack, 212-732-4300
dschustack@ceocast.com

Je krijgt het dan als een van de eersten.

P.
ludwig mack
0
mooi voor jullie;
de toestemming voor de fabriek, hebben ze die nu ook, of is dat nog een punt ...
dank voor een reaktie,
gr
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quote:

ludwig mack schreef:

mooi voor jullie;
de toestemming voor de fabriek, hebben ze die nu ook, of is dat nog een punt ...
dank voor een reaktie,
gr
Geen punt:
Calypte's Chinese Manufacturing Subsidiary Obtains Medical Device Manufacturing Permit
Thursday January 10, 9:00 am ET

Dus: fabriek goedgekeurd.

P.
gustaaf1e
0
En d.h. gesloten!
Omzet ook omhoog, maar dat mag nog wel wat meer worden de komende tijd.
G
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Dayhigh met 1K...

Time & Sales
Price Size Exch Time
z 0.11 10000 OBB 16:30:03
z 0.105 50000 OBB 16:29:58
z 0.105 10000 OBB 16:29:58
z 0.108 20000 OBB 16:29:58
z 0.10 25000 OBB 16:29:58
z 0.105 50000 OBB 16:29:58
z 0.105 45000 OBB 16:29:58
z 0.10 5000 OBB 16:29:58
t 0.125 10000 OBB 16:00:25
t 0.115 2000 OBB 16:00:11
0.125 1000 OBB 15:51:03 <========
0.12 1000 OBB 15:51:03
0.12 5000 OBB 15:48:06
0.12 10000 OBB 15:48:03
0.12 10000 OBB 15:48:01
0.12 5000 OBB 15:47:58
0.115 5000 OBB 15:37:12
0.115 15000 OBB 15:32:50
0.11 5000 OBB 15:32:11
0.11 7500 OBB 15:30:23
0.11 7500 OBB 15:30:19
0.11 20100 OBB 15:27:08
0.11 10000 OBB 14:51:06
0.11 10000 OBB 14:50:43
0.11 7500 OBB 14:50:33
0.11 7500 OBB 14:50:25
0.106 1000 OBB 14:41:26
0.104 1300 OBB 13:54:37
0.104 10000 OBB 13:38:46
0.10 19500 OBB 13:30:17


After Hours:
$ 0.125 0.00 (0.00%) Volume: 12.0 k 16:00 EST 24-jan-2008




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