The FDA does not set the expected "6 month 510K" approval times... that is the AVERAGE determined by investors. Please do not be fooled into an expecting a decision on, or even around that date.
Article from my website at BioRunUp
CXM- FDA 510k Run-Up ~ 6/3/10
May 11th, 2010 by BioRunUp
I have recently open a position in CXM for a month long play (10K @ $.516). Allow me to explain why.
On December 3rd, 2009 CXM announced that its wholly-owned subsidiary, Tissue Repair Company, submitted a 510(k) premarket notification filing with the U.S. Food and Drug Administration (FDA) seeking marketing clearance of its Excellagen product candidate based on positive data from the Company’s recently completed Phase 2b Matrix clinical study.
When the positive initial results of the Phase 2b trial were released the stock price had risen to nearly $2 before it fell victim to the “Sell on the News” mentality. Since that time CXM has fallen to a low of $.43. The 510k application was filed on December 3rd, and although there is no set time frame estimates for medical device approvals, a 6 month ROUGH estimate is usually assigned to these applications. Remember though, the FDA does not give a 6 month estimate, that is just the generally accepted consensus of BioTech. Approvals rarely come early (CAMH), and most are late. Some are VERY late, waiting 1 year or more.
For this reason, I rarely hold a 510k play past its estimated 6 month approval date. There are many, many, many traders that do not understand the 6 month estimate, they feel that it is more concrete, like a PDUFA drug date. Because of this, we usually see a rise in the share price as this estimated date approaches, and a fall in price once estimated date passes and short term investors lose interest and move on.
CXM has also experienced some erratic movement over the past few weeks, hitting $.70 on April 26th.
This being said, I have taken a position in CXM, which I will close before the estimated 6/3/10 approval date. The plan is to then move the funds into more long term October FDA plays.
Listen, I have experience in this area. If there is a surge in stock price just before June 3rd- SELL! There is not insider trading, this is just the run-up and last minute flood of misinformed investors trying to get in.
When June 3rd comes and goes the pps will begin to fall. When the price jumps to $.60+ its time to start thinking about taking profits.
well, its informative and actually i think yhoo finance should allow 3rd parties (semi and professionals) to contribute on a real time basis and offer alternate services (e.g stock picks, pf analysis, hedging strategies, etc.).
i agree a simple article/ post from an external website is usually considered as spam but its yhoo's fault because they re missing out on a great money making opportunity here
Can someone please show me, or us, where a 6-month estimate on this type of 510K comes from, along from the LONE Bio-Runup website? That is the only place I've ever seen this remotely mentioned. Granted... it's looking more & more realistic as at least a marker given we're approaching, but I've never read anything, anywhere else that hints at 6-months.
Finally someone who agrees with what I have been saying for months - there is no such thing as an "FDA deadline".
I am trying hard to be optimistic about Cardium's "products" - and the overrated (potential) approval - to me, IMHO, the longer the delay, the worse the news.