I wish the company would respond to Bioshares comments. The fda's request for a higher dose study is very positive imo, & quite rare. ............
From yesterdays Australian:
Avexa (AVX) 60c | November 28, 2007 WHEN a promising biotech falters, investors don't pussy-foot about. But was the HIV drug developer's share price plunge on Monday really justified?
Avexa shares fell as much as 13c, or 20 per cent, after industry newsletter Bioshares suggested management had been less than frank about the need to expand phase three testing of its proposed drug Apricitabine (ATC), which is designed to treat HIV patients.
At last Tuesday's AGM, management told investors that US and European regulators had approved the program and that Thunderbirds were go.
In the presentation slides, Avexa revealed the trials would require 1800 patients, compared with the market's estimate of 900-1200 takers. For scientific reasons that waft over Criterion's head, the trial also has to include a second, higher-dose study, which means more work and more costs. Avexa now needs to find a deep-pocketed partner. "Recruiting 1800 patients will be an enormously difficult task," Bioshares says, noting there are fewer HIV-resistant cases because patients better comply with medication.
Bioshares says the need for an expanded trial raises the danger of Avexa missing its target of filing for marketing approval by late 2010. "On the current time line, we expect the drug will reach the market in 2012 if there are no further delays," Bioshares says. "Investors may also be disappointed by Avexa not having the capacity to complete its phase three trials independently."
Avexa chief Julian Chick wasn't available yesterday, but others are willing to defend the company's honour. "Although we respect Bioshares' commentary, in this instance we don't agree with (their) sell recommendation," says ABN AMRO Morgans biotech team. With $70 million in cash, Avexa is in a strong negotiating position with a pharma partner.
Criterion last rated Avexa a speculative buy at 64c on September 5. Avexa had reported that 80 per cent of advanced-stage patients using ATC over 24 weeks recorded HIV amounts "below detectable levels" in their blood.
We cautiously maintain that call. Of comfort is the fact that all 29 HIV drugs entering phase three trials between 1989 and 2002 made it to the $US7 billion-a-year market.
At the very least, though, Avexa is guilty of spinning the need for a bigger and costlier trial into positive news. Investors should remember this next time the company passes around the hat for fresh funds.
