Chimerix refused to give their drug to the hardy boy under compassionate use rules. Is it possible that the FDA is stonewalling to get more boys on E without having to pay for it?
BCRX announced successful test this week of their small molecule broad spectrum antiviral against marburg 2 days post innoculation in a simian model. 100% of the subjects survived a lethal challenge. It looks to me like they are leading in this effort.
It's a good prospect. I think the analyst valuations are overblown. Oral drugs don't warrant the premium enjoyed by IV route. I put it at only 1/3 of the competing product's sales. It's as much about when things happen as what those things are. From here I see a 30% move in either direction a distinct possibility. Very unlikely this name will be in the 12-13 range 6 months from now, but the average over that time span could well be right here.
Interesting to compare todays P3 study results on perfenidine to the P2 study for eteplirsen. See ticker symbol ITMN. Perfenidine mitigates the progression of idiopathic pulmonary fibrosis. The FDA turned down their first NDA, requiring them to do a more comprehensive repeat study. Meanwhile the company did get marketing approval in europe pending the repeat P3 in the US.
Wait for 17-18 based on sell side analyst targets. I bought a small strangle this morning hoping to close out both legs at a profit. I predict it will run to 17 and then fall back to 10. I think the government money will come and it will be a huge disappointment.
A validated target is what's necessary to establish a surrogate endpoint.. IV infusion could be considered inadequate therapy that would justify accelerated approval of an oral product. This pathway enables licensure prior to a phase 3 study. Conditional (accelerated) approval allows sponsors to market a drug and simultaneously enroll patients in a confirmatory study to monitor effectiveness and safety while the producer generates revenue on the sales to fund these post-marketing confirmatory studies.
I expect the NIAID program to evaluate the broad-spectrum effectiveness of the drug, not just its marburg application. Several of the viruses showing low ED50 dosing have commercial application.
Family Virus EC50(µg/mL) EC90(µg/mL) In Vivo PoP Model
Yellow Fever 8.3 9.33 Yes Hamster
Dengue 2 13 13.05 Yes Mouse
West Nile 16 7 Yes Hamster
JEV (SA-14) 6.5 n/d n/d n/d
Rift Valley Fever 54 37 Yes Mouse
7.8 n/d n/d n/d
Rabies (Flury LEP) 9.8 n/d n/d n/d
SARS-CoV 16 n/d n/d n/d
VEE (TC83) 72 60 n/a n/a
EEE (FL93-939) 13 n/d n/d n/d
Measles 1.4 0.37 n/a n/a
Parainfluenza 3 10 n/d n/d n/d
RSV 13 n/d n/d n/d
2 5.7 19 n/d n/d
Adenovirus 60 25 n/d n/d
So what's wrong with having the government fund development of a broad spectrum antiviral for marburg that would require a partner for other targets? Dengue fever treatment is being sought by lots of companies. It has huge market potential. The only issue I see is the speed at which the USG funding drives development.
Look up "atherosclerosis" on wikipedia. There's a discussion on micro RNA at the bottom of the page. This is just one possible target example.
I think the difference is product maturity, and the unequivocal success of antibiotics. Finding that the number needed to treat is nearly 1.0 makes shorting a fools errand.