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Friday, August 15, 2014 3:47:11 PM
I'm expecting slow price increase until announcement of German reimbursement (is there anything else that could come?)
See post 17476, which reiterates some potential catalysts from Pyrr:
--Open label Ph I/II DCVax-L trial with adjuvants set to conclude this fall (possibly later). Data on 83 patients. Great confirmatory trial of sorts. This is the type of thing AA could be granted on (not that it will--it won't, but AA has been granted off a number of open label studies that confirm treatment effect).
--More Direct updates--tumor shrinkage beyond 30, 40, 50%? Adaptive Licensing approval from EMA? Breakthrough Therapy designation from FDA? All possible at any point.
--Reimbursement negotiations being finalized for Hospital Exemption. Basically any news on this pops the pps. Could be imminent, as our DD on German sickness funds timelines for orphan drugs are 6 months after approval. That would put it at late Aug/ Sept
--Simple stock pressure. Upward trending. $6 today will be $7 with pressure to buy, low pressure to sell. Supply and demand. Should cause an upward trend in and of itself. The more people see what's going on here the more will want in, and the less will want to leave.
ALSO:
* From the 10-Q, page 10/11 ...
During the six months ended June 30, 2014, the Company continued its efforts to obtain large new manufacturing capacity for its DCVax products in Europe.
* From the 10-Q, page 17:
We are a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and, through a proprietary batch manufacturing process, on a cost-effective basis, initially in both the United States and Europe.
* From the 10-Q, page 18: includes ....
expanding our German subsidiary operations
* From the 10-Q, page 21:
and compassionate use/named patient programs in other countries
* Continued updates regarding Direct phase I - early data to date
* Start-up of Direct phase II, and which cancer(s) initially selected (likely to be based on which cancer they saw best results on during phase I). Quick enrollment into this phase II might be likely and might also be a catalyst.
Pure speculation ... could a Direct phase III announcement be far behind, if the company continues to see good early "signs" & data to date in Phase I/II? Or am I being too optimistic there ... probably takes quite a while to prepare a well thought out Phase III trial. Hey ... but it would be a nice catalyst ... some day?!
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