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Fibrocell Science, Inc. Message Board

  • kjcubed kjcubed Feb 21, 2012 3:11 PM Flag

    For All of You BOTOX Pumpers - Good Read!

    This scary write up below is right from the BOTOX website. This just goes to show you that the poor women that have been scarred forever by this toxin did not take 5 minutes to read these warnings. I hope LaViv will bring them peace.

    BOTOX® Cosmetic is a prescription medicine that is injected into muscles and used to improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in people 18 to 65 years of age for a short period of time (temporary). IMPORTANT SAFETY INFORMATION BOTOX® Cosmetic may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems any time (hours to weeks) after injection of BOTOX® Cosmetic: Problems swallowing, speaking, or breathing, due to weakening of associated muscles, can be severe and result in loss of life. You are at the highest risk if these problems are pre-existing before injection. Swallowing problems may last for several months Spread of toxin effects. The effect of botulinum toxin may affect areas away from the injection site and cause serious symptoms including: loss of strength and all-over muscle weakness, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice (dysphonia), trouble saying words clearly (dysarthria), loss of bladder control, trouble breathing, trouble swallowing. If this happens, do not drive a car, operate machinery, or do other dangerous activities The dose of BOTOX® Cosmetic is not the same as, or comparable to, another botulinum toxin product. Serious and/or immediate allergic reactions have been reported. They include: itching, rash, red itchy welts, wheezing, asthma symptoms, or dizziness or feeling faint. Tell your doctor or get medical help right away if you are wheezing or have asthma symptoms, or if you become dizzy or faint. Do not take BOTOX® Cosmetic if you: are allergic to any of the ingredients in BOTOX® Cosmetic (see Medication Guide for ingredients); had an allergic reaction to any other botulinum toxin product such as Myobloc® (rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA); have a skin infection at the planned injection site. Tell your doctor about all your muscle or nerve conditions, such as amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), myasthenia gravis, or Lambert-Eaton syndrome, as you may be at increased risk of serious side effects including severe dysphagia (difficulty swallowing) and respiratory compromise (difficulty breathing) from typical doses of BOTOX® Cosmetic. (it is not known if BOTOX® Cosmetic can harm your unborn baby); are breast-feeding or plan to breast-feed (it is not known if BOTOX® Cosmetic passes into breast milk). Human albumin and spread of viral diseases. BOTOX® Cosmetic contains albumin, a protein component of human blood. The potential risk of spreading viral diseases [eg Creutzfeldt-Jakob Disease (CJD)] via human serum albumin is extremely rare. No cases of viral diseases or CJD have ever been reported in association with human serum albumin. Using BOTOX® Cosmetic with certain other medicines may cause serious side effects. Do not start any new medicines until you have told your doctor that you have received BOTOX® Cosmetic in the past. Other side effects of BOTOX® Cosmetic include: dry mouth, discomfort or pain at the injection site, tiredness, headache, neck pain, and eye problems: double vision, blurred vision, decreased eyesight, drooping eyelids, swelling of your eyelids, and dry eyes.

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    • Thanks for clarifying the issues that concern you. I'll appreciate your comments on my cost analysis below:

      IMO, the financial failure of Isolagen could be attributed to two factors. First, the cost of cell culturing in the 1990's was far higher than what we see today. Second, the FDA requiring clinical trial data killed the US market and caused serious doubts oversea. Both of these factors no longer exist. Cost for culturing has come down significantly as seen in my post and laViv has been approved by the FDA.

      FCSC has been hampered by the FDA's requirement that doctors must be trained before they can prescribe. This delayed the introduction of laViv significantly. The rapid rate of doctors being trained is a good indication that they think this is a good product. My main concern at this time is that their manufacturing facility is not yet at a scale that can handle tens of thousands of patients and funding is low to scale that up. But I believe the demand is there for laViv.

    • Yes, I am exwannabe on those boards. Just a case of I changed my handle years ago and never changed Y!.

      I do hang out on DDs board, but am not a "cohort", and the DNDN cost comparison argument was always mine, DD never made this AFAIK.

      I also do not agree with DD on demand. Never understimate vanity etc. Botox is an absurd product (cosmeticly), yet it sells.

      But back on my core point, there is of course no proof that costs will preclude success. I have backed my assertion with 3 arguments.

      1) DNDN is quite red dispite a 20x higher unit price.and decent sales volume. The costs of provenge are driven by the handling of indivual patient cells.
      2) The previous launch of LaViv was an economic disaster.
      3) FCSC has failed to provide any financial guidance on launch 7 months post approval.

      I may be right, I may be wrong. But I strongy believe that until FCSC can put a finacial plan in place, this stock goes nowhere.

      I actually will be happy to post back if in 6(?) months this starts to show a profit potential (per financial statements). I am wrong often enough that I have no problem admitting it :-)

    • The Fibonacci sequence (1, 1, 2=1+1, 3=2+1, 5=3+2, ...) is used to model a variety of natural phenomena. If this is the yahoo's alias of exwannabe, perhaps he can be more authentic than dewdiligence, a blowhard with little real knowledge.

      In any case, I did a few back of envelope calculations for the cost of making laViv. The initial nasolabial treatment requires 6 vials of fibroblasts done over three sets of injections. For potency, each vial must have between 10 to 20 millions cells. So, let's say that the total number of cells needed is around 100 millions.

      To grow that number of cells with a commercial growth media, the final step would need about 2 liters of the material. Let's say that another liter is needed for other preparation steps for a total of 3 liters of media.
      Per the above, the retail cost for each 0.5 liter is 92$. So the retail cost for media is about 552$. Since FCSC buys materials in bulk, let's say they have a 20% discount. Then, the cost is about 440$. On top of that is the costs for labor, other testing materials, facilities, etc. My guess is that 1000$ would be a good upper bound for the cost of manufacturing 6 vials. The company probably makes double that to store for future use. In that case, the initial manufacturing cost would be about 1500$.

      Rumored laViv price is 4500$ for an initial treatment. Using round numbers, my guess is that FCSC is charging about 2500$ for cell incubation, 250$ for each vial and pays 500$ to doctor. This would mean that their "raw profit" is about 2500$ per patient for the initial treatment. This business can become profitable fast as patients ramp up usage.

    • fib1,1,2,3: i stand corrected (wrong) apparently you are NOT dew/froy from ihub but instead one of his cohorts (exwannabe). i was just informed of this. in that case my apologies for assuming you were dew. the content of your post regarding cost to manufacture was almost identical to previous posting by dew, therefor i assumed you were one in the same and i was wrong. taking back the chicken chit, no balls comment. but keeping the you have NO proof on manufacturing costs as they pertain to current day.
      obviously you can detect from the tone of my previous message i have no like for dew, not because he posts contrary sentiments to my own, but because he posts bs without backing it up.

    • You are barking up the wrong tree. I do not see any issue with cost. The cost of culturing fibroblasts have improved by orders of magnitude since the 1990's when Isolagen started.

      You can buy a lab kit with 500mL medium for growing fibroblasts for under 200$ retail. FCSC only needs to pay for the medium and that costs far under 100$ for 1 liter depending on how much material they buy at a time.

      A nasolabial laViv treatment is done three times, each with two 1.2mL ampules. So the cost of raw material is insignificant. The labor cost is also not that much. As opposed to the 1980's and 1990's when at least a grad student is needed to grow cells in a lab, now this is routine even for a good high school student.

    • Hey CIN, your eyes are open, but you refuse to see.
      Your selective attention aimed at screening out disagreeable information will cost you, pal.
      Group-think investing to the exclusion of reason and substance spells disaster for any investor.

      Laviv is extortionately expensive in an aesthetic sector that is extremely competitive with cost conscious consumers.

      You should certainly take pause when FCSC mgmt announces that they will release 4th quarter earnings... on April 3?
      Am I missing something here? 4th quarter earnings for 2011 will be released after the close of 1st quarter 2012?
      Tell us why Mr. insider? I am sure it's not illegal, however; it is a bit unusual, and should give FCSC investors pause, eh.
      Folks want to see some sales, earnings, and manufacturing cost numbers, eh.

      And quit being so overly defensive and paranoid, pal. You are making folks nervous.

    • and dew/roy friedman/ karen et al in addition to the chicken chit comment, i would like to add NO balls (a reference i reserve for only a select few). btw, i'll be ambulatory for the next few days, so i await your reply! and then i look forward to your disappearance the way you did with DNDN!

    • DEW.....why the he* do you have to hide behind soooooo many alias? as long as i have posted on ihub/yahoo i've used ONE handle, why? because i don't fear/hide anything i say. i stand behind it and if i am wrong i have no problem admitting it. YOU on the other hand remind me of the sappy kid on the playground that used to hit someone and run away before the teacher showed up! in my book a chicken chit!
      you've already been outed here , so put it out there and stop hiding behind the curtain of your many personas.

      as far as your commentary on laviv cost to manufacture (which if i am not mistaken was one of your points of contention with DNDN, and where is that bashing now?), you have absolutely NO proof (btw, let your son know how to spell it correctly!)they cannot manufacture to profitability.
      btw, during my last set of injections (Feb.7) my attending physician told me specifically they had honed the manufacturing process down to perfection. this was a voluntary statement on his part, " i am so pleased with the progress they have made in processing the cells, it's amazing" quote unquote. so put that in your burrito and eat it.

    • Isolagen was an experimental treatment back in the 90s.

      FCSC (in it's pre BK name) was formed to make the process economically practicable.

      Once they launched, the COS was about twice the revenue. The BK was inevitable.

      It is now 8 months since the FDA approval, and no real word of roll out costs, They are already back to running on fumes wrt cash.

      I would suggest that there is no reason at all to beleive they can actually make this stuff cheaper than they can sell it for. Why will any real investor or partner think otherwise?

      The company refuses to discuss the core issue of cost. Do you really not see an issue here?

    • Why every time you have no argument you divert to another topic? This time to the VVUS drug which has nothing to do with cosmetics. Focus and answer me this: Can Botox and fillers do full face, decolettage, hands, acne scars, burn scars, etc.? laViv will have its own niche. As I said before, it does not need to compete with Botox and fillers. Until Allergan, Medicis and other companies create something that laViv can do now, they are not competitors to FCSC.

      Btw, just out of curiosity, why do you feel the need to post under different aliases? Feeling insecure and need to create the appearance of different people saying the same thing? Aside from the obvious foul odor of deception, being stupid multiple ways is the same as multiple times stupid!

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