Vector1,
Thanks so much for the kind words over on the Yahoo CLTR thread. I finally did go ahead and fork over the money to post on SI today... I've been somewhat averse to the idea of *paying* to see my own blabberings on the Web, but I do think that the ability to more readily ask questions of and interact with the great SI contributors like yourself will help this small investment to pay for itself pretty quickly.
Looks like our friends over at Avalon are at it again today, an item in TheStreet.com attributes today's CLTR weakness to pressure from the shorts, and quotes the Avalon analyst in particular (one David Hines). A few excerpts (I won't post the whole thing in deference to the TSC's paysite status):
"Coulter Stock Falters Amid Worries on Bexxar Filing
By Jesse Eisinger
Senior Writer
8/17/99 4:47 PM ET <snip>
"The stock, increasingly the subject of a nasty dogfight between optimists and pessimists, slipped 11% Tuesday as investors spread word that Coulter's filing for cancer antibody Bexxar wasn't accepted by the FDA. But both Coulter and its partner, SmithKline Beecham (SBH:NYSE ADR), insist that all is well, saying the agency has another two weeks to accept the paperwork. <snip>
"In a note to clients today, David Hines, an analyst for Avalon Research, which rates Coulter a sell/sell short, said, 'Since the company has failed to announce the FDA's acceptance of the Bexxar BLA filing within the 45-day window, we believe that the bull story has become very risky. We can reasonably conclude that the FDA has a problem with the BLA submission.'
"Avalon thinks there are several potential issues with the filing. For one, the company has not completed a study comparing Bexxar, a "hot," or radioactive antibody, with the antibody alone. Hines, in his note, says the company needs to complete this study before the drug can be approved. Avalon contends that the company also needs to prove that the antibody it uses from different manufacturers is consistent. "Either it goes down now or it goes down six months from now," says the hedge fund manager who is short. 'Doesn't matter to me.'"
First, as regards the hot-vs-cold study, I just can't see why Avalon keeps insisting that this trial must be completed before Bexxar can be approved - Coulter has indicated interim results would be sufficient. Perhaps Avalon has some source close to this issue, but it seems pretty farfetched to me. Lets see, the FDA is just not convinced that that the radioisotope adds any benefit versus the simple murine antibody, even after all the experience we've had with a good chimeric one (Rituxan), and the superior efficacy of Bexxar vs. Rituxan seen in these trials. Particularly in the case of *transformed* low-grade NHL, which Coulter is targeting for the label along with relapsed, we have a life-threatening unmet medical need, qualifying for priority review, but the FDA is going to tell those people that regardless of the efficacy seen in the trials, its just not sure they need the radioisotope and they'd better get signed up for a study where they might get just a murine antibody instead, and maybe some HAMA to go with it. Sure, there was some reason Coulter initiated these trials, but it may have been to bolster filings rather than an absolute requirement, and I just don't see the FDA holding up approval over this given the urgent need and the proven efficacy.
As regards the manufacturing consistency issue - finally, Avalon points to an issue worth taking a closer look at. In the current Coulter 10K, there was mention of an issue somewhat like this that I'd like to get your (and/or other contributor's) opinion on. From the filing:
"Prior to August 1997, the Company obtained Anti-B1 Antibody from an inventory produced by Beckman Coulter, and radiolabeling was performed by radiopharmacies at the individual clinical trial sites. In order to begin using Lonza Anti-B1 Antibody, BI Pharma KG Anti-B1 Antibody, and the centrally radiolabeled Anti-B1 Antibody from Nordion, the Company filed and the FDA cleared IND amendments to allow the use of these materials in clinical trials. The Company is collecting data from its clinical trials to be filed with the FDA to establish that Anti-B1 Antibody from these different sources and that Nordion radiolabeled and on-site radiolabeled Anti-B1 antibody are clinically comparable. However, there can be no assurance that it will be able to establish clinical comparability. A failure to establish clinical comparability could lead to a requirement that the Company conduct additional clinical trials, which would increase costs and potentially delay regulatory approval for Bexxar."
Any further info on this would be appreciated - I may give a call to Coulter IR sometime tomorrow to see if they can shed more light on the status of this. Nice dramatic situation here, exciting to watch...
Regards,
Gordon |
