OK, I'll do so. Thank you. I'm not affiliated with an academic center any longer so I'm in the same boat as everyone with articles. Regarding the spleen, perhaps they didn't know about the role of the spleen (it's a relatively new concept) or perhaps it wasn't important for what they were trying to show (i.e. they just wanted to sample the end organ). Their approach is sort of traditional for ischemia rat studies.
Thank you WST. I tried to pull the article, b/c this is right up my wheelhouse. I've published in the focal cerebral ischemia realm in rats. I wanted to see how they induce global cerebral ischemia. My guess is that they used bilateral internal carotid ligation which would be temporary. Appears that a fair amount of experimental data supports the use of stem cells post-ischemia. As you pointed out, this injury would simulate a global cerebral event, as in cardiac arrest or drowning. They were basically looking at stem cells as a potential competitor to hypothermia which is standard post-arrest (definitely for V-fib or V-tach). Nevertheless, it is still applicable to focal stroke in terms of the inflammatory cascade post-event.
Thank you lagatik and wildbiftek. It appears the p1b subset received 140 mg of cabo while Meteor uses 60 mg of cabo. The p1b had a PFS of 14.7 months, while the p3 assumes a PFS of 7.5 mths for cabo. Since safety isn't a major concern with cabo and 140 mg was overwhelmingly successful, why reduce the dose? Of course, it's always prudent to minimize dose to minimize AE's. I hope EXEL had a good rationale for this dose selection.
As a matter of disclosure, I'm very long this stock and was in it for Comet. I didn't sell as I saw value in Cobi. I am a MD but not in oncology.
Results of p2 are impressive in small numbers. Statistically difficult to conceive of negative results in p3. Other than the resident short, is there any there any good argument for a negative result?
You're right, I can't find it either. It seems that I misheard and mixed up EMA and FDA in this regard. My sincere apologies to the MB... I hope I didn't cause anybody undue stress.
You're exactly correct about the EMA. The FDA AA statement was made about 5-10 minutes prior to that I believe, during the question session. I can't remember the exact question but it was regarding specifics of the their last informal sit-down with the FDA. CG did state that the FDA commented in a non-binding way that the current data set did not meet criteria for AA. I was very surprised by that statement. However, he also said that they will go back to them with the additional data and pose the same question. I'm sure this will all be in the transcript.
Bottom line for me is that this is the best DMD drug out there with excellent safety. I don't believe the FDA will be able to say no once they have the ADCOM result and political pressure from advocacy groups. I just hope they don't delay this by not granting AA.
Thanks for your synopsis of the interesting points. I also thought it was interesting that CG stated that the FDA did not feel the data supported an accelerated approval at this point ("nonbinding" statement), but that they would reconsider this at the next meeting. The discussion re: the EMA also seemed bizarre. From what I gathered, they don't have enough to submit at this juncture and the apparent problem was the N. It was stated that they would consider re-approaching the EMA at the time of a potential FDA submission.
Thanks yags and stillinshock. Yes, I forgot the possibility of a financing. Clearly, there is no way they can proceed with p3 without more cash. Unless there's a partnership deal for p3 or a new sizable deal (with another vaccine), this is a likelihood.
As far as Dr. Kim, his words no longer carry any weight. He's lost credibility IMO. I agree.
Guess we should add opportunity cost to the list. You got that right. Basic economic concept. Without some proper demand, this may keep falling. Demand will only come from some critical news item. It needs to happen soon.
If they guess on where something is going to go, eventually by luck they will be right here and there. You don't remember when they are wrong...
My opinion on factors moving this down:
1. General negative sentiment after loss of partnership
2. Bitterness overhang after reverse split
3. Lack of significant news/quiet time for company (note, initiating a trial is not a pps moving event)
4. Relatively low volume in recent trading sessions
5. Leniency in allowing naked shorting
6. Impatience of the individual investor and the street in general
7. Technical downtrend
8. Shorts able to push price given all the above factors
9. Oh and by the way, it's a very bad day for many biotechs.
This is how I see it. MHO only. This retrace is EXTREMELY painful
I didn't thumbs down you, but I don't believe these earnings will provide any additional insight. They will be a recap and what to expect. Perhaps they will update the status of Meteor, but I doubt it'll be anything to greatly affect share price.
I think this was referenced a few days ago. This is a remarkable potential treatment for HIV. I wonder if many might see this as a competitor to INO's HIV vaccine, and it may very well be. But it can also be viewed as a potential for effective combination treatment. I sort of wish that Inovio gets a move on with these therapies, because the competition is out there. But I'm happy for those with HIV as this is a possible breakthrough.
I was thinking the same exact thing this AM. I'm still surprised that they didn't make a stab at buying the company after the last cobi trial. Why not buy on the cheap when you know this combo will get approved? Often this has a lot to do with BP politics and their shareholders, but you're right, now they will end up paying a lot more.
Sentiment: Strong Buy
what happens if the trial shows some hints of positivity but fails in a classical sense. This may be ok for Japan but not necessarily in the US. How will the market react to that? That is my bottom line concern. I don't know how to protect the reaction to an unconventional marketing approach that many may not understand.
It was a good call. THere has not been a decision made on a SPA yet. Apparently, this hasn't been discussed with the regulatory bodies either. Any potential decision on a SPA will not cause a delay to the beginning of the trial, which is 2nd quarter. The strange thing was that another executive from CYTK stated that the ALS quality of life scale will be part of the study endpoints, but not necessarily primary. Reading in between the lines--they will ask for a SPA.