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FCSC - Fibrocell Science Inc - Page 2

post #21 of 36

Fibrocell Science, Inc. Submits Final Data from Histology Study to FDA



"The Company’s final study report contained data from the 29-patient blinded study (IT-H-001). FDA participated in the design of the protocol and data analysis plans. As was the case with the three-month report, there were no unexpected results in the six-month report, and the study provided additional data to support the azficel-T safety profile seen in the clinic."
“This study, which objectively evaluated the effect of repeated azficel-T injections at three months and six months, has met all expectations. As anticipated from the extensive prior clinical experience, no clinical concerns were identified by either direct or comparative observations of the cellular morphology and integrity of the dermis, subcutis, or epidermis when biopsies from tissue treated with azficel-T were compared with either placebo-treated or untreated tissue,” said James Merritt, M.D., Clinical Advisor to the study and Chief Medical Officer of CBR International Corp., a Colorado based research firm who provided medical advice to Fibrocell during the study. "The detailed microscopic analysis of tissue treated with azficel-T during this study support Fibrocell’s response to the CR letter, and we believe we have met FDA requirements.”
They completed exactly what the FDA wanted and found zero issues. This will get the green light IMO. This first approval is just a gateway to many other approvals coming for many other uses, take a look at the investor presentation.
post #22 of 36

I'm in pretty heavy on this one. If the get approval in June it's going to already be around $2 (due to insider buying etc) then pop probably over $4.


Good luck all.



post #23 of 36

Looking good lately.  Lets get this sucker to $2  so I can sell and move on.  Being an old BMR stock there may be good odds they pump it again.  If they do it will move fast past my $2 target.



post #24 of 36

Not really sure why you think this will go to $2, let alone $4.

post #25 of 36
Originally Posted by aceline View Post

Not really sure why you think this will go to $2, let alone $4.

Because they have a PDUFA date on 06/22


I did sell 1/3 of my position today 1.00 and 1.05   Only to try and buy back around .90 and because owning 30k shares of a .OB gets scary LOL


Upgraded today with a price target of $3



And the $4 target of mine is only if they get a favorable panel vote then FDA approval.



post #26 of 36

nice job man... im still holding all of mine from .60 smile.gif


I recommend you guys take a look at the investor presentation and the 2nd video i posted on the first page... Really puts the companies potential in perspective.

The only thing hindering this company right now is lack of funds. It is very possible the R&R PR is just a pump so FCSC can raise some $$.. (ahem BPAX).. but, im sticking it out until June.

post #27 of 36

 When I looked it seemed to me that had plenty of cash to make it to the end of the year.  But you never know with these.



post #28 of 36

No sir, from the 10k:



As of March 24, 2011, the Company had cash and cash equivalents of approximately $3.4 million and current liabilities of approximately $0.6 million. The Company’s current monthly cash run-rate is approximately $1.0 million. The Company is also planning to purchase manufacturing equipment and incur marketing expenditures within the next three months to prepare the Company for launch post a possible FDA approval. Thus, the Successor Company will need to access the capital markets in the near future in order to fund future operations.


They need either partnership or loan... if they dont get either of those, its dilution.

post #29 of 36

 Being 2 months away from the PDUFA date they have enough to make it..at least to that point.  But at least they do not need to raise a crap ton of money LOL.. And if they were smart they would get a pop into(or after) the PDUFA and then sell shares. Stupid to do it now unless they know it will go bad(or are afraid it will)


I'm down to 20k shares anyway. Hoping it gaps and runs up to 1.20 tomorrow or more.. Then I will sell more. Holding way better than I though above $1 today.

post #30 of 36

another solid day here.   Should continue to climb as we get closer to PDUFA date



Im averaged in at .96

post #31 of 36

what a beast this one is. I sold half my position today, now riding all 'free' shares avg at .60 .. Plan on holding all the way near PDUFA. Still havent decided how much i want to hold through PDUFA. I do believe they will get approval.

post #32 of 36

so who is holding what on this one?

post #33 of 36
post #34 of 36

Jeez what a disaster this one was post approval.. i hope everyone got out before the plunge. I managed to get out at 1.44 with the rest of my shares. I did say it will get approval IMO... but didnt say any pps lol


This still has potential as a long term hold, but im not in it. On to the next one...

post #35 of 36

ACUR did the sane thing

post #36 of 36

and now LCI  down 4%

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