The only way to really do that is make the primary endpoint from the very beginning as clearance of hpv virus with secondary endpoints of lesion clearance--thus targeting across pathology. But they didn't do that and im glad they didnt--too risky. 0% chance FDA lets them do as you suggest.
They have already started p1/2a in other hpv related indications. They may expand further still. Btw, the 3100 vaccine are therapeutic, nor preventative.
I'm a little taken aback by this.I know its not dilution until they officially offer up the shares but why would they draw up a shelf right now?
LOL, if you buy a stock based on analyst recommendation, that is pretty funny. Analysts are usually a waste of time.
Expectation were met. The abstracts were fantastic. The run was capped by concerns over toxicity (Stiefel), which given the landscape of treatment options, are not legit IMO. There were numerous posts discussing the topic.
If the AdCom is relatively unbiased like they should be, I don't have any concerns for approval for SRPT, for the reasons you mentioned---safe and effective to some degree--also has shown reasonable durability. Everything I've been reading about Drisa is less than impressive. It seems like Biomarin has influence and deep pockets--I would be very disappointed if they got the nod from the ADCOM.
You're right on. Considered selling yesterday at 27 in anticipation of this but I couldn't do it because my horizon is long term. This is always hard to watch regardless
All the negativity was predictable. Appropriate and classy rebuke by Roth
-completion of NDA
-ADCOM date notification (same as BMRN?--this could eliminate any temporal advantage they have)
These are the definite things I can see in the future. I'm sure there will be surprises as well. GLTA and congrats to longs.
If it is a combined AdCom, it will be one of the most interesting one's in recent memory. The little guy with the seemingly better drug vs the big boy with more influence (and seemingly less effective more toxic drug). The community needs at least 1 drug.
Wilder, I agree with your reply. The landscape is constantly changing in all fields. Take, for instance, hepatitis C---the SOC was ribavirin, pegylated interferon, etc and now a single oral tab is 95%+ successful with less side effects. I'm not an oncologist and don't follow the landscape as I do in my own specialty. Are there a particular class of medications that you view a threat to Cabo and its progression? The PD1 inhibitors, for instance, I doubt would be effective as a solo agent. GLTA.
Wilder, I believe its reasonable to search for a predictive biomarker, but this may be difficult or nonexistent. The key is that the SAE's are still clinically manageable and don't lead to death. Cabo has already gone through 3 phases of development with MTC and has seen a significant amount of post-development use. To conclude at this juncture that there are significant safety concerns is simply ludicrous. Of course, the FDA does monitor drugs post-approval, as serious AE's often become prominent during this time-period, but that is not the case here.
I agree with you completely but dont forget that safety is monitored at every phase. Often the larger n's of p2 &3 brings out safety concerns not seen in p1. Whats different here is very obvious--the drug is already on the market. So I think Stiefel is way off base and at least I wonder if this is intentionally
Every option Ive ever bought, there was a period of time where I would have made good money. The option game is all about timing. As an investor, you can control more shares with less capital through options . Of course, the risk of losing your premium (and all of your money) is high
I don't like this because it shows how corrupt Trading is. Regardless, I think you're 100% correct. It will be pegged at 3.50.