Alnylam: Further Evidence That The Stock Is Overvalued [View article]
@SeekingValue - You also fail to mention what the money means to each party. ISIS really needs the money, ALNY did not. However, Alnylam management/team are quite incompetent when it comes to doing actual drug development, they need Genzyme to show them the ropes.
More Uncertainty Ahead For Threshold [View article]
When drugs have overlapping toxicities, it is typically not going to be possible to combine them at therapeutic doses.
@ TruffelPig - After reviewing your previous comments, it's pretty clear that you are endlessly biased on all your stocks. Maybe take a step back. Threshold is behind both ZIOP (by > 1 year) and CELG (by > 2.5 years) with a drug that doesnt look better than either.
Alnylam: No Approved Drugs, No Promising Candidates, No Justification For $1 Billion Valuation [View article]
Nice valuation short call. It also seems possible Alnylam won't beat GSK/ISIS to market in TTR either. Following the news that ISIS/GSK will run a pivotal Phase 2/3 does not bode well for ALNY.
Sarepta Therapeutics: Stock Rising Too Far, Too Fast? [View article]
I respectfully suggest Mr. David Zanoni stick to writing about non-biotech, since after looking thru some of his articles on them, he clearly has little expertise in the area.
You're trying to make a technical short call on a stock whose fundamentals have risen dramatically because of their pipeline. This is how biotech works. Technicals are BS in biotech. PCYC and MDVN kept going straight up regardless of some of the stupid commentary people made on the underlying technicals.
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
I dont know how you could possibly read what I wrote and think it supports PPHM.
(1) Bavi likely has little to no effect on KRAS given its MoA; it does not target pathway mutations.
(2) Given DTIC's performance in one of the worst mutational groups, you expect much better performance in the portion of patients without KRAS aka OS > 6 months by a lot. Consider a recent large Phase 3 study that showed OS in 2L NSCLC of 10 months! Although a bit high compared to some previously run small Phase 2's, it is a large randomized Phase 3 study
Herbst 2010 ("Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial")
"However, in the present study, the median overall survival of 10 months for patients receiving placebo plus docetaxel is longer than that reported in the earlier studies. This difference might be explained by differences in the availability or use of first-line and post-progression therapies, as well as general improvements in standards of care over time."
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
OS result of <6-month in docetaxel arm is way too short to be credible.
- ARRY recently reported OS in 2L NSCLC (stage IIIB and IV) who are KRAS positive: Overall survival was longer for selumetinib in combination with docetaxel compared to docetaxel alone (9.4 mo vs 5.2 mo; 56 events, median follow-up 219 days).
KRAS positive patients have significantly worse prognosis, so there is likely something wrong with the randomization or baseline levels of patients are not equal across arms.
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
Some more red flags to make one cautious
- Trial unblinded in May and failed ORR/PFS. No way around this; no p-values or Hazard Ratios reported. Now the company is touting an unofficial endpoint in OS.
- Another red flag with touting such a purportedly large OS benefit is why haven't placebo patients switched over Bavi after unblinding?
Maybe PPHM got lucky, but this is risky data to hold through IMO.
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
(1) How did you leave out the fact that the top-line data in 2nd line NSCLC FAILED??????!!!!! No HR's or p-values listed are highly indicative of a failed study, however PPHM isn't an honest company, which is why they didn't report them.
(2) How did you forget to mention the study failed in 1st line NSCLC? No benefit, it's just a placebo based on these data.
"Based on independent central imaging reads, patients demonstrated a current median PFS estimate of 6.7 months for the bavituximab-containing arm and 6.4 months for the chemotherapy-only arm. Peregrine expects to report median overall survival (OS) from this trial in the second half of 2012. "
(3) A quote from you: "As of July, 2012, the majority of patients were still alive with Bavituximab, so the MOS wasn't able to be calculated yet. That's an extra two to three months that the patients have lived their lives, which is significant and the biggest reason why the stock has gone on such an epic run since June."
This couldn't be farther from the truth, just sickeningly speculative. ARRY reported OS almost 2X the SOC in their trial and it only gave a p-value of 0.2. You are disregarding how the survival curves look and how small this trial actually is. Given how small this trial is, I am willing to bet the OS results will not be statistically significant as well.
(4) Given the large number of ex-US clinical sites for this trial, hard to believe any results will hold up in another trial. Russia, India, Ukraine.
Orphan Drug Designation Biotechs For Investment Consideration [View article]
You do know that INO/Genetronic ran a very similar trial and it failed miserably; didnt even complete enrollment. Deemed unsafe by DMC during an interim analysis.
Alnylam: Further Evidence That The Stock Is Overvalued [View article]
Alnylam is a wildly speculative stock.
More Uncertainty Ahead For Threshold [View article]
@ TruffelPig - After reviewing your previous comments, it's pretty clear that you are endlessly biased on all your stocks. Maybe take a step back. Threshold is behind both ZIOP (by > 1 year) and CELG (by > 2.5 years) with a drug that doesnt look better than either.
Alnylam: No Approved Drugs, No Promising Candidates, No Justification For $1 Billion Valuation [View article]
Could It Be An 'Alzheimer's Bonanza'? [View article]
Oncolytics Sharply Overvalued Following REO 018 Trial Failure [View article]
Navidea Biopharmaceutical Undervalued Approaching FDA Decision [View article]
Knight Capital's Rescue Deal - A Lesson For Biotech Investors [View article]
Stop dancing around this. Do you believe it? Probably not. Whatever boosts the share price for you.
Also, the company has been dealing with CMC issues for over 5 years and still no fix. Nice CRL today.
Sarepta Therapeutics: Stock Rising Too Far, Too Fast? [View article]
You're trying to make a technical short call on a stock whose fundamentals have risen dramatically because of their pipeline. This is how biotech works. Technicals are BS in biotech. PCYC and MDVN kept going straight up regardless of some of the stupid commentary people made on the underlying technicals.
Peregrine: Bavi Results Are Overhyped And Inconclusive [View article]
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
(1) Bavi likely has little to no effect on KRAS given its MoA; it does not target pathway mutations.
(2) Given DTIC's performance in one of the worst mutational groups, you expect much better performance in the portion of patients without KRAS aka OS > 6 months by a lot. Consider a recent large Phase 3 study that showed OS in 2L NSCLC of 10 months! Although a bit high compared to some previously run small Phase 2's, it is a large randomized Phase 3 study
Herbst 2010 ("Vandetanib plus docetaxel versus docetaxel as second-line treatment for patients with advanced non-small-cell lung cancer (ZODIAC): a double-blind, randomised, phase 3 trial")
"However, in the present study, the median overall survival of 10 months for patients receiving placebo plus docetaxel is longer than that reported in the earlier studies. This difference might be explained by differences in the availability or use of first-line and post-progression therapies, as well as general improvements in standards of care over time."
Hanna 2004 - 7.9 months
http://bit.ly/Pwt26S
Kim 2008 - 8 months
http://bit.ly/P29m71
So yeah, seeing < 6 months means something is up.
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
- ARRY recently reported OS in 2L NSCLC (stage IIIB and IV) who are KRAS positive: Overall survival was longer for selumetinib in combination with docetaxel compared to docetaxel alone (9.4 mo vs 5.2 mo; 56 events, median follow-up 219 days).
KRAS positive patients have significantly worse prognosis, so there is likely something wrong with the randomization or baseline levels of patients are not equal across arms.
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
- Trial unblinded in May and failed ORR/PFS. No way around this; no p-values or Hazard Ratios reported. Now the company is touting an unofficial endpoint in OS.
- Another red flag with touting such a purportedly large OS benefit is why haven't placebo patients switched over Bavi after unblinding?
Maybe PPHM got lucky, but this is risky data to hold through IMO.
Several Catalysts Are Near For Peregrine Pharmaceuticals [View article]
http://bit.ly/P9Ugz3
(2) How did you forget to mention the study failed in 1st line NSCLC? No benefit, it's just a placebo based on these data.
"Based on independent central imaging reads, patients demonstrated a current median PFS estimate of 6.7 months for the bavituximab-containing arm and 6.4 months for the chemotherapy-only arm. Peregrine expects to report median overall survival (OS) from this trial in the second half of 2012. "
http://bit.ly/Rk2KH4
(3) A quote from you: "As of July, 2012, the majority of patients were still alive with Bavituximab, so the MOS wasn't able to be calculated yet. That's an extra two to three months that the patients have lived their lives, which is significant and the biggest reason why the stock has gone on such an epic run since June."
This couldn't be farther from the truth, just sickeningly speculative. ARRY reported OS almost 2X the SOC in their trial and it only gave a p-value of 0.2. You are disregarding how the survival curves look and how small this trial actually is. Given how small this trial is, I am willing to bet the OS results will not be statistically significant as well.
(4) Given the large number of ex-US clinical sites for this trial, hard to believe any results will hold up in another trial. Russia, India, Ukraine.
http://1.usa.gov/N6eCot;rank=6&show_l...
Orphan Drug Designation Biotechs For Investment Consideration [View article]
http://bit.ly/Ogjwzs
A Long Shot In The Lupus Market Gains Attention [View article]