Day 3. at this point, flat or long, imo. showing strength. too dangerous to be short. IMO Great trade though from $250 in a short period. IMO
Thank you for the thoughtful reply. The issue here isn't binary... either the drug gets approved or it doesn't, either the next news is positive or negative. Nope, the issue is... even if everything goes perfectly for PBYI, at your wildest dreams, what kind of value do you put on a cancer drug (with side effects) that may help you live a couple months longer. Well, not $3.6 billion... especially with so much wood to chop before it might actually get approval. There are much better drugs in the collective pipeline not that far behind that will make PBYI obsolete in short order... again, even if everything goes as best as you can hope.
It's okay to be short this stock, as you clearly seem to be, but what is really 'repelling' is your command of the facts.
A readout on NSABP (FB-7), which is expected before the end of July, could in fact boost this stock appreciably if it comes in positive. Your absolute statements show you really don't understand the levers of this drug's story. If you are just a trader, that's okay, but there is no way you can jawbone this stock down based on posts. It's too beat down. Back to FB-7, based on prior studies of Neratinib against Herceptin (e.g., I-SPY), expectations are high Neratinib should win both the doublet with Taxol and show a nice triplet number when joined with Taxol and Herceptin. Keep your short on as you see fit, but that seems like a dangerous trade to hold right now. Wouldn't be surprised to see covering accelerate for those who have traded well on the short side the last 5 weeks (opinion).
Finally, the drug isn't "mediocre" by any stretch. It has shown signals in myriad settings and beaten the SOC in some settings. The real question is Neratinib's safety profile. If the G3+ diarrhea can be managed down, as some very small trials indicate, sentiment could shift dramatically. We'll see. Again, stay short if you want to bet against both the NSABP readout and an improvement of safety. My opinion remains that both are more than in the stock already.
End of July... under $100. There is nothing that is going to rally this stock. Sure, there might be a couple of up days, even in a row. But this thing got way over inflated, and reality is settling in. This is a very mediocre drug with repelling side effects.
Although from trials with very small "n's", several recent Neratinib readouts indicate the real possibility/likelihood that adding prophylaxis loperamide could take G3+ diarrhea down into the teens or even single digits for compliant patients. Equally notable, the duration of the GI issue appears to be cut dramatically--to something on the order of 2 days.
So, with those early data points in mind, your assertion is that you'd accept what appears to be an appreciably higher risk of recurrence for a roughly 1 in 10 chance of G3+ distress, which may in fact be a short, first cycle effect. Utterly nonsensical.
Granted, if loperamide doesn't work (we'll know soon as a P2 is being run to determine duration and severity relief, if any), incidence of G3+ diarrhea in the 40% to 50% G3+ range is very high, but all indications are that may not be the case. As always, the trial details will tell us the truth, but if it can be managed that far down, it would seem the storyline around this drug could shift very fast (opinion).
HR 0.67 and 0.51 for locally and central lab assessed HER2 status; 0.49 and 0.25 for hormone positive HER2+ patients depending on how to assess HER2 positivity. The last number is phenomenal for a cancer drug.
One caveat is that they need to finish IHC on all patients to get a complete picture of subgroup analysis results.
Suffice it to say I agree with your sentiment, if not the exact numbers you cite. If the prophylaxis loperamide improves Neratinib's safety profile materially to, say, the teens or better (as has been shown in very small trials already; HER2+ MBC and HER2+ mutated NSCLC, as single agent and in combination with Torisel) with compliant patients on therapy, it's hard to imagine this drug not being very, very successful over time (opinion).
To that end, don't forget NSABP (FB-7) could come any time now and could provide yet another data point in that regard, and with a much bigger "n". Also, the now in-flight P2 ExteNET follow-on, due by YE, also seeks to determine to what degree prophylaxing might lessen degree and duration of G3+ diarrhea. Unclear why shorts aren't more concerned those might change the storyline in one fell swoop. Given the aforementioned prophylaxis successes, it's seems very risky to bet against it (opinion).
This is really silly. The FDA and scientific community use HR to evaluate drug effect in this case. Ask a HER2+ breast cancer patient after taking Herceptin for a year whether she wants to take a medication that can lower her risk of recurrence by 33%, or more accurately by 75% while potentially experiencing non life threatening side effect, what do you think her choice will be?
Isn't that very obvious?
My dear, even Herceptin, the holy grail of targeted therapy, does not show a difference greater than 10%, not even remotely close.
The issue with Neratinib ExeNet trial is, that the data are complicated to fully understand. The local testing vs centralized lab testing for HER2 IHC messed things up (0.67 vs 0.25 HR, a big difference), and the HR in hormone positive patient polulation (HR=0.51) have people worried about labeling and potential limited use in resitricted patient population.
The recent study published with placebo was not a sugarpill but was Herceptin which is the current standard of care (SOC). Neratinib performed well against this SOC
Placebo is not a sugar pill.....it is Herceptin. Neratinib is compared with the Standard of Care (SOC) and it proved to be even better.
If that's the case the CO mgmt needs to put a PR out explaining the stats and the differences. Until, then short sellers will use what was mention as a problem in their reporting.
NSABP (FB-7) is next expected Neratinib readout, and could come anytime in the next five (5) weeks based on company guidance during the Goldman call earlier this month. Notably, the trial and data are NSABP's, so Puma is beholden to their timeline. It is a neoadjuvant trial that replicates design of previous NeoALLTO study and has a three arm design of Taxol/Herceptin, Taxol Neratinib and Taxol/Herceptin/Neratinig.
The deeper ExteNET data is already here (ASCO), unless you're talking about 3 year numbers that could come at YE (San Antonio, one would think). Also, article is to be published on recent ExteNET details in roughly the next four (4) weeks, based on company guidance. Although seemingly unlikely, article could serve as a catalyst depending on it's content--i.e., if it differs from ASCO narrative, introduces new advocates, explains science of 'cross talk' with HER-2 and HR, etc. Finally, carcinogenicity results from in-flight P2 (in preparation for expected Neratinib adjuvant NDA filing in early 2016) could also come later 2015, although the company hasn't, to my knowledge, said they'd release any detail about them. (Because it's the last piece of the filing puzzle, one would expect them to announce that obstacle being removed should it come through clean, which is generally expected as TKIs have a good track record in that regard). The could be an MBC trial update as well around YE too.
and diarrhea. The squirts are really hitting the fan now. Please tell me how you rationalize a $1 billion valuation? That's a $30 stock price. Could be below $100 before the end of the month.