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CEL-SCI Corporation Message Board

  • ccot2008 ccot2008 Dec 4, 2009 9:55 PM Flag

    Validation is NOT a requirement to Open

    Can anyone find a PR from another Pharma company about getting their new plant "validated" before it opens?

    I believe there is a grave misunderstanding amongst shareholders here. CEL-SCI will open the plant when "they" (CEL-SCI Management) believes that the plant can hold up to an inspection. ie. people, training, policies & procedures are in place.

    Until it is operational, what is there to really inspect? Proper ventilation? The right equipment? Any US Gov't Inspections I have been made privy to were on a surprise basis and was always inspecting a live operation.

    Novartis had an inauguration for their plant,,,that doesn't mean that Obama goes there and takes the oath of office.

    http://www.novartis.com/newsroom/media-releases/en/2009/1356789.shtml

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    • Much as I hate to stand up for CVM, it may be the FDA's delays that are holding things up. The FDA is way, way behind its own schedule on device approvals. The FDA, for example, is six months late on its own deadline for a Nephros device approval, and other biotechs are experiencing the same problem. A couple of executive bureaucrats have been replaced. That kind of thing indicates to me the whole agency is not operating efficiently.

    • Agreed. My point is that bashers are saying we haven't heard anything because it failed the validation. I'm just saying that can't be as the FDA will inspect it after it is open (ready for business),,,ie CVM Management is confident it is ready. Until we see news saying it's open, we won't hear about the FDA inspection. Part of the inspection is of the manufacturing process. Can't inspect what isn't happening yet.

    • where are they going to get this money to operate this plant? Dilution!!!!!!

      • 1 Reply to furlongdanielj
      • well they have about 40 mil and dillution might scare you are some other people but

        Now if you want to talk o/s now considering the facts, look at it like this a company like p&g has 2.9 billion shares market cap at 184 billion and only make 12-18 billion a year. their market cap on a good year is 10 times what they make. Okay so then look at cvm lets say when Multikine hits the market they have 500 mill shares which I doubt they will have that much. They will make around 4 billion a year,market cap times 10 would be about 40 bill divided by 500 mill shares. that would put them at around 80 dollars a share, I am happy with half that, then they take that income and bring leaps to the market if not already, and the arthritist market can bring in billions also. Man I dont know maybe I should sell because these bashers extensive research scares me.

        Just to add took a quick look at Teva net income 2.6 billion a year. 912 million outstanding shares, market cap at 49.2 billion at 53 dollars a share. bashers get over it. Its not scary I know you wish it was.

        you could go on and on with companies and market caps, but remember its your choice to sell or buy, or hold at these prices,

        for day traders and week swingers, they might worry about dillution or the 40 mill on the shelf for longs as far as dillution they dont have that much, they have about 40 mill cash and 40 mil on the shelf. that should be enough to get through phase 3, and remember they can get approved before fda in europe and make around 3 billion.

    • Don't be a clown!
      How many PRs from CVM repeated THEY EXPECT the plant to be validated in the final quater of 2009>>>?
      How many?
      So they put it out there....not us.

      • 1 Reply to cmegladon
      • Did any of the PRs say by whom the validation was being done?

        Per the FDA: (This describes a live environment)

        How does FDA determine if a company is complying with cGMP regulations?

        FDA inspects pharmaceutical manufacturing facilities worldwide using scientifically and cGMP- trained individuals whose job it is to evaluate whether the company is following the cGMP regulations. FDA also relies upon reports of potentially defective drug products from the public and the industry. FDA will often use these reports to identify sites for which an inspection or investigation is needed. Most companies that are inspected are found to be fully compliant with the cGMP regulations.

    • last I heard on paper, besides what you can find on bio med calender dates.


      the facility in itself has already been cleared by design by the FDA and the validation that is currently ongoing is internal to Cel-Sci. The internal validation will ensure that the facility meets, and then can maintain, the standards of an FDA inspection which could occur at any time. The inspections, according to Dr. Talor, have become more frequent since Multikine will now be tested in a fairly large patient population during the Phase III trial; up to 800 patients, according to the trial design described on the Cel-Sci website.
      http://biomedreports.com/articles/most-popular/14683-inside-cel-scis-new-multikine-production-facility.html

    • Typically a plant like this has to go through equipment, utility, and process validation. Only then will the plant be able to produce product (i.e. Multikine) in accordance with CGMP standards. CGMP are the Current Good Manufacturing Practices followed by the pharmaceutical and biotech firms to ensure that the products produced meet specific requirements for identity, strength, quality, and purity.

      http://www.gmpcompliance.net/CGMP_Defined/CGMP_Defined.htm

      Getting through this process is no easy task, but from what I read on this board it sounds like CEL-SCI is getting close.

 
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