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Collagenase phase III
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10/05/2003 23:31
randy

not registered

10/05/2003 23:31
randy

not registered

Collagenase phase III

Can anyone advise on the status of phase III trials for collagenase injections? Have they started or when will they start? I have found on the net that Biospecifics manufacturing plant has received approval so that sounds good but have not been able to find any definitive update on status of actual standing on the phase III trials. Would appreciate any concrete information anyone may have, thanks.

10/05/2003 23:14
crayton

not registered

10/05/2003 23:14
crayton

not registered

coll phase 3

Randy...

All I saw was that a new trial was seeking patients..can't remember where. can't believe this study is going on 5 years now...very frustrating.

cb

10/05/2003 23:48
randy

not registered

10/05/2003 23:48
randy

not registered

collagenase III

clinicaltrials.gov shows the study not yet open for recruiting, email to Dr. Badalamente has been unanswered.

10/05/2003 23:51
crayton

not registered

10/05/2003 23:51
crayton

not registered

collagenase III

I'd sure like to hear from her on the holdup. The white papers I've read really support this procedure. do you have her email?

10/06/2003 23:32
Mike M.

not registered

10/06/2003 23:32
Mike M.

not registered

Given up hope on collagenase trials...

I have personally spoken with Tom Wegman (Executive Vice President, BioSpecifics Technologies Corp) and corresponded(via e-mail) with Dr. Marie Badalamente (Dept. Orthopaedics, SUNY Stony Brook, NY) on three occasions over the past few years. Mr. Wegman was very clear in indicating that, due to lack of funding and FDA scrutiny, the phase III trials and future of collagenase therapy for DP is years away at best. In fact, Biospecifics is barely solvent (read their 2002 annual report) and the company's future is uncertain.

My advice is to not wait for the collagenase therapy and instead seek other options. Personally, should my hand nodule (dormant for two years) begin to progress toward contracture, I'm headed for Paris for an 'in-and-out' round of Dr. Badois NA.

The NA technique seems to produce the same basic results as the more intrusive surgery and involves virtually no post-operative trauma and rehabilitation. If I were to have a recurrence after a few years, I'd just make another trip to Paris for a tune-up. Recurrence rates appear to be statistically similar to those of surgery.

What are the relative costs of non-insured NA (plus travel) to insurance deductibles and co-payments for surgery and rehabilitation? Probably insignificant given what I've read, and who wants to deal with the post-operative trauma and rehab of surgery?

I've read this forum for over two years now and have yet to hear a complaint about NA. With NA, it seems as though you can have the procedure one day, and have nearly full use of your fingers the next day. I can't imagine why anyone who is a candidate for NA would not give it a try before opting for surgery. In my mind, there is just no logic to a dissenting opinion...none.

Mike

10/06/2003 23:19
randy

not registered

10/06/2003 23:19
randy

not registered

info on Dr. Badalamente

Contact info for her off the net:

Dr. Marie A. Badalamente
mbadalamente@notes.cc.sunysb.ede
631-444-1489 of 631-444-2215

I have not received any response on request for info on updates on phase III trials, maybe someone else will have better luck.

We are all hoping that these trials will progress and the treatment a possibility in the future but who knows. If anyone gets any factual update, please post. Thanks.

10/06/2003 23:57
Mike M.

not registered

10/06/2003 23:57
Mike M.

not registered

Giving up on collagenase trials...

I have personally spoken with Tom Wegman (Executive Vice President, BioSpecifics Technologies Corp) and corresponded (via e-mail) with Dr. Marie Badalamente (Dept. Orthopaedics, SUNY Stony Brook, NY) on three occasions over the past few years. Mr. Wegman was very clear in indicating that, due to lack of funding and FDA scrutiny, the phase III trials and future of collagenase therapy for DP is years away at best. In fact, Biospecifics is barely solvent (read their 2002 annual report) and the company's future is uncertain.

My advice is to not wait for the collagenase therapy and instead seek other options. Personally, should my hand nodule (dormant for two years) begin to progress toward contracture, I'm headed for Paris for an 'in-and-out' round of Dr. Badois NA.

The NA technique seems to produce the same basic results as the more intrusive surgery and involves virtually no post-operative trauma and rehabilitation. If I were to have a recurrence after a few years, I'd just make another trip to Paris for a tune-up. Recurrence rates appear to be statistically similar to those of surgery.

What are the relative costs of non-insured NA (plus travel) to insurance deductibles and co-payments for surgery and rehabilitation? Probably insignificant given what I've read, and who wants to deal with the post-operative trauma and rehab of surgery?

I've read this forum for over two years now and have yet to hear a complaint about NA. With NA, it seems as though you can have the procedure one day, and have nearly full use of your fingers the next day. I can't imagine why anyone who is a candidate for NA would not give it a try before opting for surgery. In my mind, there is just no logic to a dissenting opinion...none.

Mike M.

10/06/2003 23:43
Randy H.

not registered

10/06/2003 23:43
Randy H.

not registered

We Have Lift Off!!

Ladies and gentlemen,

I just got off the phone after talking to an administrator at BioSpecifics who told me in no uncertain terms that Phase III has begun at Stony Brook. She did not confirm or deny my statement that "Funding issues must be the reason that the UCLA and Stanford sites have yet to begin". She simply said "But Stony Brook has been underway for two months."

I don't expect this news to be believed until some of you have confirmed this information. Please do.

Randy Harris.

10/06/2003 23:40
jim h

not registered

10/06/2003 23:40
jim h

not registered

Jim H., please read what you~sq~ ve referenced...

Not hard to believe at all. Biospecifics arranged some new financing a few months ago. Not huge, but enough to get the trials going. They also resolved their problem with FDA approval of the manufacturing plant.

Best way to find out about Biospecifics is to go to something like the Yahoo finance page and enter BSTC. Read the recent news and SEC filings. The story is all there.

10/07/2003 23:25
Mike M.

not registered

10/07/2003 23:25
Mike M.

not registered

Jim H., please read what you~sq~ ve referenced...

Jim H.,

As you indicated, "the best way to find out about Biospecifics is to go to the Yahoo finance page and enter BSTC. Read the recent news and SEC filings. The story is all there."

Well, I have been regularly following this exact reference for a few years now (BSTC at Yahoo Finance, SEC Filings, Summary) and let me provide an excerpt from their 8/14/03 quarterly report summary:

"Since February 1, 2000, our (Biospecifics) revenues have been insufficient to cover our expenses, and we expect operating losses to continue while we attempt to return to normal manufacturing operations. The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The carrying amounts of assets and liabilities presented in the financial statements do not purport to represent realizable or settlement values. The Company was dependent on the FDA approval it received and has suffered operating losses over the period of Curacao facility renovation. The Company currently has limited liquidity. These factors raise substantial doubt about the Company's ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of those uncertainties.

As of the date of this quarterly report, we have limited cash resources available to fund our operations. Although we obtained FDA approval of our Curacao manufacturing facility, we must obtain additional funding by the end of 2003, at which time our cash reserves will be nearly depleted based on our projections. We are engaged in efforts to obtain more capital through various alternatives. There can be no assurances that these efforts will be successful.

The Company was notified by The Nasdaq Stock Market that the Nasdaq Listing Qualifications Panel (the "Panel") determined to continue the listing of the Company's common stock on The Nasdaq SmallCap Market pursuant to the following exception:

On or before August 14, 2003 and November 14, 2003, BioSpecifics must file the Forms 10-QSB for the quarters ending June 30, 2003 and September 30, 2003, respectively with the Securities and Exchange Commission and Nasdaq, evidencing continued compliance with all requirements for continued listing on The Nasdaq SmallCap Market.

The Panel reserved the right to terminate or otherwise modify the terms of this exception subsequent to a review of BioSpecifics' publicly filed financial statements. In order to fully comply with the terms of this exception, BioSpecifics must be able to demonstrate compliance with all requirements for continued listing on The Nasdaq SmallCap Market. In the event BioSpecifics fails to comply with any of the terms of this exception, its securities will be delisted from The Nasdaq SmallCap Market. There can be no assurances that BioSpecifics will be able to meet the requirements of the Nasdaq exception."

Jim, I am not trying to be a downer here, just simply a realist. The excerpt from Biospecific's 8/14/03 quarterly report summary in my view is anything but uplifting and it appears to me that this company is in serious financial trouble. In fact, when I contacted Tom Wegman (Executive Vice President, BioSpecifics Technologies Corp) some months ago, he was asking me if I could organize a fund raising campaign among potential DP patients to help subsidize their operations. Now, in my view, that's a desperate act.

I would gladly contribute money to the research effort at Biospecifics, but I am not sure how effective such a fund raising campaign would be.

Anyone have any thoughts?

Mike M.


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