....something they should have done a long time ago, instead of ripping the shareholder off via massive dilution.
Ph I - is it safe? Yes
Ph II - Does it work? Maybe
Ph III - is it better than previous treatments? Yes(there are no cures for dry AMD & SMD)
"Once all the necessary evidence has been obtained, a new treatment must be submitted to the regulatory authority: The European Medicines Agency (EMA) in Europe, or the US Food and Drug Administration (FDA) in the USA. Any stem cell therapy must meet the specific requirements of Europe’s Advanced Therapy Medicinal Product (ATMP) legislation to obtain a licence. These agencies typically take 1-2 years to review the data, will ask hundreds of detailed questions and charge a fee for this assessment process. The initial application submission can also cost around #$%$300,000 (US and EU fees combined) although these fees are reduced for small companies and sometimes waived entirely."
Getting the treatment to patients
"If the licence application for a new treatment is approved, then the organisation that developed the new medical product begins a long process to obtain payment from health systems and health insurers in countries where the treatment is to be used. In Europe this payment or reimbursement process takes place country by country and in the USA state by state. Additional evidence is sometimes needed to support the price requested for the product. It can take several years after approval of the product licence before healthcare providers and insurers begin to pay for the therapy. There is currently considerable work being done to develop systems that enable patients to get breakthrough treatments for unmet medical conditions more rapidly whilst this long process is continuing. The FDA in the USA has set up a system called expanded access and similar systems are under consideration at the European Medicines Agency."
Thinking that they can go it alone seems to be a mistake that many of the small companies make!!!
In a way, it's sort of understandable because the super Subject Matter Experts in science, engineering, medicine, etc. think that they either know it all or can learn it all. Quite frequently, they only discover what they don't know after disaster strikes!!!
"Thinking that they can go it alone seems to be a mistake that many of the small companies make!!!"
Black, I think it was greed on ACT's part(Gary saw dollar signs dancing in his head) is why they've never took on a partner to help finance this thing. And it didn't help when Caldwell tragically passed away and Gary Rabin took the helm as Chairman & CEO in 2010, because if there were anyone with less qualifications to run a biotech company than Gary you'd be hard pressed to find them. Although Caldwell messed up the financing of this big project big time,too. Now we're stuck with a bean counter running things , but you'd think the BOD would step in and rectify this matter, especially Dr Langer who has phenominal credentials in the biotech field. It's just mind boggling they we're still stuck with inept management.
Re: ....the US Food and Drug Administration (FDA) in the USA............
beareclawe • Feb 7, 2014 8:43 PM
O T : US Federal Appeals Court Sides With FDA: Propagated Stem Cells Are a Drug
Posted on February 4, 2014
'Knoepfler Lab Stem Cell Blog'
A long-standing debate in the commercial stem cell arena has focused on whether stem cells grown in a lab prior to clinical use as a transplantation product are biological drugs subject to full FDA vetting. The alternative view has been that such stem cell products are not drugs, but rather are simple human cellular and tissue products.
That debate, at least operatively, would seem to be over with a ruling today by the federal D.C. Court of Appeals supporting the FDA position that stem cells grown in a lab are in fact drugs. The decision came on an appeal of a lower district court ruling in USA v. Regenerative Sciences case, which had also supported the FDA position.
Morning Keep,, what makes you think that it will take such a long time for reimbursement,, I think once this thing gets started that the money is going to fly, unless there is something I don't know that you do,,
"I think once this thing gets started that the money is going to fly, unless there is something I don't know that you do,,"
Doc, ACT still has away to go before commercialization, but a merger partnership would or be a step in the right direction. And I believe they've proved safety is not an issue after 3 years(Ph 1). And it's apparent, eventhough management is playing mum & dumb, that ACT can improve visual acuity even in the worst cases(20/400 to 20/40 patient(Ph 2). And since there is no cures for AMD & SMD, ACT's cures will sail them through Ph 3. ACT has the science, it's the management that still needs fixing.
Finally, once ACT gets into Ph 2, I believe that the EMA(European Medicines Agency) will allow them to start commercialization of their cure for macular degeneration. And lets not forget that MMD(Macular Myopic Degeneration) will be following right behind AMD & SMD. Also, the Tufts Vet Clinic doggie therapies should be complete in couple more months, and that could start bringing in some much needed revenue.