Replies to post #83170 on Biotech Values

[bladerunner1717]

re: ALTH

This is a Medical Technology Stock Letter Special Update for Wednesday, September 02, 2009.

We are pleased to update that Allos Therapeutics’ lymphoma drug candidate, Fototyn, received a 10-4 vote in favor of approval from the FDA’s panel of outside experts this afternoon. In what was a very tough meeting in which the FDA called into question confirmatory CT scans that were not obtained for 13 of the 29 responders. The FDA’s briefing documents also had concerns that efficacy was not completely proven because there were no confirmatory scans of response after the initial response designation by central review. Despite these FDA concerns, ALTH did a good job of presenting and proving to the panel that they stuck to the clinical protocol. Today was a very good day for ALTH shareholders and an even better day for PTCL patients who will soon have a desperately needed new treatment option.

The positive FDA panel vote is a tremendous achievement for the company. It is important to remember that this was an FDA “advisory” panel meeting and is not an FDA approval, even though the FDA usually follows their recommendation. One can probably not over-estimate the importance of having the FDA signed off on an SPA, special protocol agreement, for PROPEL before the trial was conducted. Peripheral T-cell lymphoma (PTCL) patients who have relapsed are a very needy group who have no other treatment choices, and have relapsed despite having been treated with up to twelve different drugs. ALTH retains worldwide rights to Fotolyn which could lead to either partnerships or an outright acquisition. There are not many cancer drugs available that are this close to the market. The PDUFA date for the drug candidate is September 24, which means that the FDA could approve the drug by that date. The fact that the FDA convened an FDA panel in front of the PDUFA date adds to our confidence that ALTH will get a positive nod by September 24. We expect the stock to open up higher tomorrow morning, but we will would not chase as there should be some “sell the news” after the initial gap up. That being said, we are strong holders of ALTH as much of the risk has been removed. We will monitor ALTH closely as we may raise the buy limit after the dust settles. For now, ALTH is a strong hold and the target remains $12.



Bladerunner

[turtlepower]

ALTH - I am skeptical that the FDA will make a decision by the 24th and also that a decision will be positive. On one of the two previous occasions the fda granted accelerated approval the results in terms of response rate and duration were a lot better and on both occasions the companies had run two single arm trials.

"The FDA has based some approvals of oncology drugs on single-arm trials, Pazdur noted.

Eisai Inc.'s Targretin (bexarotene) was granted approval for CTCL in 1999 based on response rates of 54 percent and 45 percent in single-arm studies, with response durations of 107 days and 159 days, respectively. Merck & Co. Inc.'s Zolinza (vorinostat) also was given full approval in 2006 on the basis of response rate in two single-arm studies of patients with refractory CTCL, Pazdur added."

http://www.bioworld.com/servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=51977

I listed to the CC yesterday and management stated that they had not submitted any material yet for another clinical trial. I consider that a huge red flag signalling at the very least a huge delay for a decision by the FDA. Given pazdur's prior history with Provenge I can only assume the worst.