better snap up shares. they hinted at conference today that fed approval in u.s. may come in november.
if that is the case this trades around $4.00 mark.
Agreed, but you should not assume that large pharma will jump in after seeing the first PII trial results either, right????
The full data set has been available for confidential review by interested parties for some time now...still no nibbles
I have been holding CYCC for a couple of years. It took more than six month to negotiate a SPA with the FDA. Nothing happens fast with the FDA, so you do not want to set yourself up for disappointment. Be patient, it will pay off in the long run.
FDA negotiations will likely be longer than 6 months from the inital meeting. The company is still interested in developing their proposed bystander effect story, which will require a PII trial to look for appropriate markers before commiting to a PIII trial design.
On a positive note, the recent presentation at the NY Academy of Science mentioned preliminary results in mice on transferring response through isolated spleen cells. If that data can be replicated and expanded on it would be the first solid piece of evidence that the bystander effect may in fact be immune mediated, and not the result of drug leaking from the injection sites. That would be interesting news.
For now, I am planning to sell my current position on or shortly after the Nov 4th presentation in Australia, but will continue to look at PVCT investments as a $ generating opportunity down the road.
Lets see the full data set before anyone jumps to conclusions. If the data is as good as we hope it is, Large Pharma will join PVCT and help them design the Phase 3 trial appropriately. I own some stock, so I am biased....but for every human beings sake, I am hopeful that pv -10 does what the company says it will.
Not sure that you can compare the DNDN vaccine and PVCT trials. There are abundant papers describing the vaccine schedule, antibody titers, clinical outcomes. For PVCT you have "we inject the tumor >> something magical happens >> bystander tumors go away (actually, if you look at the ASCO poster quite a few metastatic sites got bigger after skin injection of PV-10).
While the company wants investors to thing that the "something magical" step is an immune mediated effect (with no data to show, but it sure sounds sexy) we also know from the ASCO poster that ~50% of the injected skin dose is absorbed systemically (into the blood) and delivered throughout the body. There is more indirect evidence that the 'bystander effect' is a direct result of RR leaking into systemic circulation than there is evidence of an immune activation ( I have a side bet that if the company would simply calculate the total RR dose injected per Patient body weight, the "bystander" effect would be easy to explain.
With regard to the target price prior to the Nov 4 PR on PII trial results, a reasonable estimate is between 1.35 to 1.6, just like the speculative run up before ASCO.
The complexities of PIII trial design are more involved than you suggest, but the key for investors to think about is that the design of the PIII dictates what can be claimed in promotion in/when PV-10 gets to market approval steps. If you do not document the immune mediated mechanism you can not make the claim when trying to sell the drug. design is key now...PVCT can not be sloppy here. NO way you will see a pop to $5..stop inhaling.
Company doesn't say it has all the exact answers to explain the amazing results, neither dndn to this date, reg immune system mechanism.
FDA doesn't need a 1+1=2 explanation to award an SPA. they would shape the trial (ie as you say double arm etc..)to understand more, yes i agree. But if an spa gets granted, we will be at 5$ in a matter of hours.
I agree with you that there will PROBABLY be some correction in the price post phase2 data. But from which top?... i think if the phaseII data is very good, the price will be very high, simple as that. a bit of correction is not a problem for me.
As for now until phase 2 release, i think momentum will prevail but that is not really important.
You might want to do your homework before you pump a stock. They are in Phase 1 clinical trials. They still have Phase 2 and it needs to be successful and then they can APPLY for FDC approval. Looking at probably 3-4 months minimum but as investing goes the company looks strong with $8m infusion and solid success rate on Phase 1 trials. Hope this helps you all. Check out history of DNDN. similar scenario and you'll see what buy on rumor sell on news is really all about.
Well i've done my home work my friend. i suggest you take a look at their website and you'll see that their phase2 is completed. They'll report phase 2 data in november. Phase 2 data release is always a MAJOR milestone for any biotech. Institutions come in at that point.
So, yes....you are a morron.
also; we're talking FDA here, not really FDC.