Contract no: 6528 Name: Kit simulare adsobtie citokine CYTOSORB pe PRISMAFLEX - 100 buc.
V.1) Date of Contract Award 24.12.2015
V.2) Number of offers received 1
Number of valid offers 1
V.3) Name and address of economic operator to whom the contract has been awarded
SMART MEDICAL SOLUTIONS S.R.L.
Address: Str. Ghiocei, Nr. 27, Et. 2, Ap. 4, sector 2 , City: Bucuresti , Postal code: 020042 , Romania , Phone. +40 730710557 , Email: officeATsmartmedicalDOTro , Fax: +40 314329947 , URL: wwwDOTsmartmedicalDOTro
V.4) Information on value of contract
Total Final Value of the Contract (Initial estimated total value of the contract)
Estimated value: 666060.00 Currency: RON VAT free
Value: 666060.00 Currency: RON VAT free
V.5) Contract is likely to be subcontracted
V.6) Lista de Loturi
Why FDA should ask a PK trial with lower amlodipine dose if the PH III trial was with full dose ??
"According to FDA requirements, a similar PK bioequivalence study for the KIT-302 product, containing a lower dosage (2.5 mg) of amlodipine will be conducted by the end of this year"
•Blockade of the progestogen-PR is an untested strategy for breast cancer prevention.
•TPA opposed the pro-hyperplastic effects of MPA in mouse mammary glands.
•TPA decreased tumor incidence, pHH3, angiogenesis, and ER/PR expression in rats.
•Physiological estradiol plus progesterone increased the growth of T47D spheroids.
•TPA and UPA are superior to mifepristone in growth suppression of T47D spheroids.
Blockade of the progestogen–progesterone receptor (PR) axis is a novel but untested strategy for breast cancer prevention. We report preclinical data evaluating telapristone acetate (TPA), ulipristal acetate (UPA), and mifepristone.
Tumors were induced with medroxyprogesterone acetate (MPA) plus 7,12-dimethylbenz[a]anthracene (DMBA) in mice, and MPA or progesterone plus N-methyl-N-nitrosourea (MNU) in rats. Mammary gland histology, tumor incidence, latency, multiplicity, burden and histology were evaluated, along with immunohistochemical labeling of pHH3 (proliferation), CD34 (angiogenesis), and estrogen and progesterone receptors (ER and PR). A concentration gradient of TPA, UPA, and mifepristone was tested for growth inhibition of T47D spheroids.
In mouse mammary glands, no tumors formed, but TPA opposed the pro-hyperplastic effects of MPA (p = 0.002). In rats, TPA decreased tumor incidence (p = 0.037 for MPA + TPA vs. MPA, and p = 0.032 for progesterone + TPA vs. progesterone) and tumor burden (p = 0.042 for progesterone + TPA vs. progesterone), with significant decreases in pHH3 and CD34 positive cells. TPA and UPA were superior to mifepristone in growth inhibition of T47D spheroids.
TPA has consistent anti-tumorigenic effects in several models, which are accompanied by decreases in cell proliferation, angiogenesis, and hormone receptor expression.
NO. I just wonder how an update that, it's my opinion, is worthy to share with investors, it is not shared publicy (facebook is a social network, not a PR platform). I think that the fact that for the first time Cytosorbents and Fresenius organize and do marketing togheter in an internetional conference is a new that me, like retail, would like to know not reading a message board, but having my PR on a finance site or in the company home page. JUST MY OPINION
Vittorio Emanuele hospital is one of the main hospital of Sicily. Noatably is the fact that just one hospital orders about 100.000$ of cyotosorb catridges for one year. We could extrapolate for 100 hospitals about 10 mil$/year.
the document also states that cytosorb is "essential for the care of critically ill patients admitted to intensive care units"
Vittorio Emanuele Hospital Catania (Italy)
About 84K#$%$ RFP for Cytosorb catridges
INDIZIONE GARA TELEMATICA (RDO) TRAMITE MERCATO ELETTRONICO DELLA PUBBLICA AMMINISTRAZIONE PER LA FORNITURA DI FILTRI CYTOSORB PER LA RIMOZIONE DELLE CITOCHINE DA DESTINARE ALLE UNIT� OPERATIVE DI RIANIMAZIONE E LE TERAPIE INTENSIVE DELL?AZIENDA. IMPORTO COMPLESSIVO A BASE D?ASTA #$%$ 84.000,00 (OTTANTAQUATTROMILA/00) IVA ESCLUSA