It was reposted from rocky on icell.........now all of you p izz off..........
The e-mail beow was a response to poster "twenty2's" questions posed to ACT's Matt Vincent,
Director of Business Development. The response is 17 months old but much of what was said
back then by Vincent is what we are hearing today....thought it was worth a repost and thanks
again to twenty2...bolding/underlining below is mine...thanks
With Permission Granted From Matt Vincent, I Would Like To Share The Following:
Good morning John!
Many thanks for your note. It was great to meet you at the shareholder meeting this past June. I hope you have had a wonderful summer since then.
As we have not said much publicly about the phase II trial design, there is only so much I can say about it in this email. It will be longer than the Phase I study (which will run about 1 year), but not substantially longer. I anticipate that Phase II will take from 18 – 30 months. Sorry to give you such a wide range, but until we have provided more details publicly I need to keep my comments within the context of what we have already presented. That being said, I took a look at the thread around video and think I understand the context of your question – can we afford to go through Phase II without a partner. We do have a reasonably good understanding of the costs associated with the Phase II arms to each trial, and between our cash on hand and the equity line we have in place, we could advance both IND’s through Phase II without sacrificing the other programs we continue to make excellent progress advancing toward the clinic as well.
It was enlightening to see the various efforts to “read the tea leaves” from my discussion on the BioPharm panel last week. And I cannot tell you how much appreciated the positive things that folks said about me – it means a great deal to each of us at ACT to know the support we have from our shareholders. So thank-you, you are wonderful. I would add this around the partnering discussion though on the thread, at least to clarify. As I mentioned, the typical big Pharma disposition these days around clinical and preclinical opportunities is a desire to see phase II data before real partnering considerations are made. There are plenty of exceptions to trend for sure, and our SMD and dry AMD trials are designed such we have some unique opportunities even within the current trends. Indeed, it is clear from the meetings we have been attending that ACT is being closely followed by many of the big Pharma and biotech companies. I think more than one person picked that up in Garry Neil’s (J+J) comments.
While our phase I study is designed for safety, we have a unique opportunity through imaging of the retinas of our patients to follow RPE cell engraftment and photoreceptor activity, and along with a variety of other tests our patients are undergoing we hope to be able to produce relevant physiological data that would be of interest to potential strategic partners even before the commencement of Phase II. The calculation for us, if a potential partnership were put on the table to consider before we began Phase II, will be whether the economics of the deal (and what that money would mean to advancing other programs) and the manpower and experience that the partner could bring to bear make sense when compared to the potential increase in value of the program that a positive Phase II trial might have (factoring in the risks of the trial as well) if we were to fund the trial ourselves and wait. The bottom line is that I believe we are in the very fortunate position of having many many more choices when compared to most other companies out there with products moving through the clinic. As Gary would say, all options are on the table for consideration. It is a very exciting time.