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Saturday, 04/10/2010 1:50:36 AM

Saturday, April 10, 2010 1:50:36 AM

Post# of 15766
Adam F. is back bashing ANX again (sort of)...

He had some good and then some bad things to say about ANX-530 in today's Biotech Stock Mailbag post on thestreet.com

My comments are in bold...

http://www.thestreet.com/story/10721681/4/biotech-stock-mailbag-vertex-pharma.html

Moving on. An email from Duncan P.:

"In a recent press release from Adventrx Pharmaceuticals(ANX), it was stated that the company will meet with the FDA in the last week of April to review the rejection of the ANX-530 New Drug Application. Do you foresee this meeting having any impact on the stock price, positive or negative?"

In the following paragraph, is it ANX-530 or ANX-520?...A good journalist wouldn't allow a typo like this...

Adventrx shares took a hit on March 1, when the company received a "refuse to file" letter from the FDA, turning away Adventrx's approval application for the chemotherapy drug ANX-530. In the letter, the FDA said drug stability data from the third-party commercial manufacturer of ANX-520 was insufficient.

As Duncan points out, Adventrx is meeting with the FDA in the last week of this month to determine what sort of (and how much) drug stability data on ANX-530 is needed for the agency to accept the application for review.

Here he does it again...Is it 520 or 530?...He can't even follow through in the same freakin' sentence...What an idiot...IMO

Adventrx CEO Brian Culley has already said the company is planning for a "worst-case" scenario in which the FDA will require 12 months of stability data on ANX-530 that comes from the actual manufacturing facility to be used for the commercial supply of the drug. If this is what the FDA asks for during April's meeting, Culley has said Adventrx could resubmit the ANX-520 application in six or seven months because the needed drug stability testing of ANX-530 is already underway.

See how this clown exaggerates, adding a few extra months to the time line before resubmission can happen?...Culley stated six or seven months more data was needed from the new manufacturer on March 1st when the RTF Letter was issued...So add six or seven months to March 1st, and they may be able to resubmit the NDA as early as September...Which is THREE months earlier than what Adam F. is saying...He always tries to make things look as bleak as possible...

In round figures, let's just say this scenario has Adventrx re-filing ANX-530 in December, so all in, the drug is delayed by a year.

He actually says something fairly positive here:

Getting back to Duncan's main question, if Adventrx can emerge from its FDA meeting with a requirement of less than 12 months of new stability testing of ANX-530, then Adventrx may be able to re-file sooner. That should be good for the stock.

Doh!...Try telling us something we didn't already know you fool...Does he actually hint at a glimmer of hope the FDA will bend their rules a bit and allow the data that was originally submitted?...

Whether or not Culley and his team can convince the FDA to lower its manufacturing requirements won't be known until Adventrx updates investors after the meeting.

But of course, he has to end his story on a sour note as usual:

For the record, I'm not too high on the commercial prospects for ANX-530, as I've stated in previous Mailbags.


Who cares if it's $20 million or $200 million a year of potential market share?...What he always fails to talk about is how important it is to get the proprietary emulsion process itself VERIFIED with a FDA approval!...And how important it would be for this company to just get ONE drug approved and bringing in REVENUE, which is something they've NEVER been able to do before...We all know 530 is just a drop in the bucket compared to what 514's potential market share is...

This article came out at 7am on Friday, and I'm surprised I missed it...But I've been working on getting our taxes ready to file next week, and my attention hasn't been totally on the market like it usually is...

All I've got to say about Adam Frackenstein is: I'm GLAD that a company finally filed a quarter of a million dollar lawsuit against him and thestreet.com for questionable journalism practices...A link to GNBT's lawsuit PR:

http://www.globenewswire.com/newsroom/news.html?ref=rss&d=188084

And I hear another company is about to follow suit...No, it's not ANX, but if I ran the company, I'd be all over these clowns in a HEARTBEAT!...In today's Conference Call, the CEO of CTIC said he was also going to sue Adam F. and thestreet.com for an undisclosed amount...I sure hope they win the lawsuit, and put these people out of business of GOOD!...Here's a link to the CTIC webcast:

http://phx.corporate-ir.net/phoenix.zhtml?c=92775&p=irol-newsArticle&cat=news&id=1411430