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Biotech / Medical : CLTR COULTER PHARMACEUTICAL -- Ignore unavailable to you. Want to Upgrade?

To: Bob L who wrote (477)	1/13/2000 12:38:00 AM
From: Vector1	Read Replies (2) \| Respond to of 666

Report from CLTR presentation at HQ. I thought CLTR make a very impressive presentation at HQ today and during the breakout the company elaborated on the much discussed delayed BLA filing. The primary reason for the BLA delay are difficulties in formatting the data in a manner that lends itself to an electronic filing and gives the FDA biologics division which has limited statistical resources the ability to extract the data they need. The company realized after meeting with the FDA that the process would be interactive and the the company would have to in effect act as staff statistician for the FDA and prepare analysis for them. Realizing that this would take a long time the company decided to update the data from the trials which make up the submission. The company did this to try and enchance thier label since the data is positive given that one of the main advantages of Bex is the length of the remissions it induces. The company was careful to say that they could not give an exact date on the filing but noted that significant progress has been made recently and expected to give the street guidance in about two weeks. I view this as good news and expect the filing to occur sometime in April. That is my view the company did not say that. While I can be fairly cynical (not as bad as Biowa) and I have been quite critical of CLTR for not being more interactive with the FDA from the beginning, I must say that I found Bingham to be sincere and highly credible. I think for better or worse the company has been caught in a situation where the Biologics division at the FDA has precious little time to review a very complicated filing and at the same time is trying to convert to the digital world. CLTR is the guinea pig. No time to whine about it they just need to deal with it and I think they are. The big positive of this story is the efficacy of Bex which is being proven over and over again. The company confirmed that in the Bex stand alone trial that had in the mid 60s complete response rate, over 2/3s of the CRs were at the molecular level. In my view this is quite impressive. The company repeated the ASH data on the Fludarabine trial. Indeed the company reported that to date only 3 patients from that trial (out of 30) have relapsed. IMO Fludarabine plus Bex will become the gold standard in NHL. In addition the company reported that the have completed enrollment of the trial on patients that have failed Rit. This is exactly the same trial that IDEC reported on at ASH for Zev with IMO mediocre results. NO COMPLETE REMISSIONS. The Bex data on patients who have failed RIt will be reported at next December's ASH. The timing is not coincidently around the time Bex will likely get approval from the FDA. The company said that the next ASH could not come soon enough and I can understand why. If the data on Rit refactory patients is good you can sign the death warrant for Zev. I remain extremely bullish on this stock. V1