East Bay Business Times June 19, 2003 Cardima looks to revive microcatheter
Fremont-based Cardima Inc. said Thursday it has started discussions with the U.S. Food and Drug Administration on how to gain premarket approval of its microcatheter system - which was rejected by an FDA panel last month.
In a statement, the company said it will meet with FDA officials to discuss its data and the necessary process to gain approval for its Revelation Tx device, designed as a minimally invasive, single-use, microcatheter to treat atrial fibrillation, a heartbeat irregularity.
An FDA panel recommended against approving the product, saying efficacy data wasn't "sufficiently clear" and supportive for approval. The FDA is not obligated to follow the panel's recommendations but usually does so.
The move chopped nearly 60 percent from Cardima's market value. The stock was trading at $1.93 before the panel issued its recommendation; it closed at 84 cents Thursday.
It appears that there was still some hope at the end of that day for a quick FDA resolution. But that hope has slowly faded.
Excepting any giant surprise, it seems that this company will need to establish a new following in the coming months.
There is also the very real possiblity of substantial selling soon for tax reasons.
It is certainly not a sure thing and obviously no one is chasing this stock, even below .70. I think we will have ample opportunity to buy in the .55 to .65 range - if not lower!
Even then, it is far from a sure bet, in spite of all the BS and claims of "manipulation" that we see from angry longs. From the little I can gather independent of this board, EU sales have been a disappointment to date, and it is going to take lots more cash to keep this afloat. Competing technologies are also a factor.
Best wishes to the rational investors and traders. The paranoid whiners should find another hobby.
(Is this a cue for the next "ring," whomever that may be. Hahaha. Only the rings know for sure.)
Just for clarification, the last paragraph you posted may be what was published, but the prices it contains are not (and were not) accurate.
"The move chopped nearly 60 percent from Cardima's market value. The stock was trading at $1.93 before the panel issued its recommendation; it closed at 84 cents Thursday."
Here's what actually occurred:
CRDM was trading as high as $2.18 on the day before the FDA sub-panel hearing, May 28, in aniticipation of FDA approval.
Late the morning of the 28th Reuters published a report containing the questions asked by the sub-panel staff in preparation for the hearing. The Reuters "report" contained the reporter's opinion that the staff questions made it appear Revelation Tx would not be approved. Based solely on that report, the price of CRDM dropped from $2.18 to as low as $1.02 before it began to recover and closed on May 28 at $1.21
At 7:30 a.m. on the day of the sub-panel hearing, May 29, CRDM was halted and remained halted the entire day. It did not resume trading until the morning of May 30 when it opened at .57, traded as high as .93 and closed at .78