Some interesting posts from the GP board for consideration, this group of stockholders are well versed about the company from a science POV ( Ithink some are in this field) as far as I can tell. The last few minutes today were quite unexpected in s/p movement esp for a Friday PM close. IMHO
Ceasar to advanced-cell-.
show details 11:58 AM (10 hours ago)
Hi Jand D,
I was working late last night and was reviewing all my assumptions and data points relative to my posts on JV Potential and my RS issue response. I wanted to be very sure of my positions.
Please take note of exact quotes from Lanza:
"Of course, as we hopefully will succeed with our clinical trials and move into phase three intervention, and hopefully phase four – manufacturing and very, very large numbers of patients – obviously that is not our area of expertise, so we’d be partnering with other groups and companies."
I have read this interview a couple of days ago but its more immediate impact did not hit until last night. I am therefore using Lanza's statments to connect my own data points and timelines to re-verify the 2 conclusions that I proposed yesterday.
These 2 among others are:
1. That a JV announcement is imminent.
2. That there is no need for an RS because of the pending JV announcement.
Lanza's comments solidified my two conclusions after I realized the following:
1. There are very solid reasons to fast tract both our SMD and AMD Trials. These reasons are a) our interventional RPE Treatment is more substantially preventive, and thus will be more effective in saving patient's vision when the patient is treated as "early as possible" from the point of diagnosis.
2. From a compassionate stand point alone these two INDs should be fast tracked.
The other discovery (aha!), I realized last night is full impact of the word "dovetail" relative to the protocols, and possible shortcuts that ACTC, the FDA, and the Doctors, just might be able to do relative to these two seemingly independent trials.
The fact is these two trials in fact dovetailed and are related!
Let me put it this way... if the Stargardt dosing is succesfull, do we need the Phase 1/2 for the Dry AMD Trials? Note that the Patient population demographics are the same, the protocols are the same, and the RPE Cells used are the same! ACTC therefore should propose to the FDA that if and when the Stargardt's trial proved to be safe and effective, then the two trials can proceed to Phase 3, at the same time because of "Equivalency"
If this is the case, Lanza's statements above makes absolute sense, including the use of the word "dovetail" by Caldwell.
If we pull back at this point, and create a hypothetical NDA approval timeline for the 2 ACTC INDs, we can very well have a product that should be available to the public within 2 and a half years or earlier.
If this is the case, ACTC will have to choose a JV partner for the SMD/AMD Programs RIGHT NOW because it will at least take 2 years for the JV Partner to ramp up and prepare for all the activities that will have to be done prior to the new product introduction!
If you guys will read back the other portions of Lanza's most recent interview, it is an investment goldmine. He also referred to the possible univeral blood IND that I am so excited about. But hate typing, and I easily get bored.
You can do that yourselves. LOL.
Best and Good Luck!
Cuenca
On Dec 3, 2010 7:01 PM, "Ceasar de Cuenca" wrote:
Hi Feeeeed,
I neglected to explain why the JV decision by ACTC will have to be made now or in the next few weeks/months.
One of the key words that Lanza used during the interview is the outsourcing to the JV of the "value chain" from the Manufacturing all the way to Sales.
Note that any JV for the Myoblast Phase 2 will be less attractive considering that CardioVascular Trials will take much, much longer than the SMD/AMD, I, therefore, concluded that Lanza is talking about the SMD/AMD JV.
Additionally, when Lanza talked about millions of patients, then I know that he is not just talking about Stargardt... he is also talking about Dry AMD .
It is therefore safe to assume, that the SMD and Dry AMD will dovetaile each other in terms of NDA approval, and it is also safe to assume that both will get fast tracked!
Now, if we connect this information, to the fact that It will take at least two years to build an organization and its supporting resources including at least 100 to 200 people, build a plant, decide packaging, labeling, including your QA, plus all of these have to be GMP approved by the FDA, the STATE, and the Countries involved... Lanza's statement absolutely makes sense.
If you build, a 30% delay factor into your planning schedule and the fact that ACTC might get a product approval to Market its RPE cells to the SMD/AMD markets in the US and Europe... then you will see why there is an absolute need for ACTC to make a decision on their JV now, or in the next few weeks.
These pieces of information will also make logical sense when you include Lanza's other statements about conducting trials in Europe.
In conclusion, FEEEEEEEED, your target is much closer than you think! LOL.
-----------------------------------------------------------------------------REgarding the Lawsuit
Cuenca
Ceasar de Cuenca to advanced-cell-.
show details 7:37 PM (3 hours ago)
Hi BigRedFed,
The courts nor NIH will have no bearing on ACTC. The Instutions and the Market will quickly recognize that if the courts and NIH goes negative then ACTC will have a virtual monopoly together with its JV Partner. Note that a negative decision by the courts and NIH will shut down most of the research, and ACTC with its JV and Geron will be way ahead of everybody else in this new Industry. The JV, the Institution, and the Smart Money will know this and they will be buying.
Besides, ACTC can not keep this close... they will have to announce within a day, to comply with the SEC.
Also, I think the uptick, is due to the leakage of a positive NIH decision. I hope.
Cuenca
Jckrdu to Advanced
show details 8:23 PM (2 hours ago)
Agree. After the last negative court ruling, most stem cell stocks
took a hit, but ACTC released a PR a day or so after saying they were
uniquely positioned (NED lines) to likely not be impacted by the court
decision. That PR immediately took us higher. I expect essentially
the same PR would be released again if the court ruled against hESC,
and thus it would be a very short-term impact / buying opportunity.
