If you believe GC (big "if" at this point), no.
Post# of 30028
Posted On: 10/21/2016 12:56:05 PM
If you believe GC (big "if" at this point), no.
Lonza worked for 2 years with the FDA to get the clinical hold removed and get a clean slate and distance from Permaderm's problems.
Here is what GC said:
"So, previously, problems were there were some noncompliance issues significant noncompliance issues in earlier clinical studies. There was certainly questionable credibility of the data generated to date, as some--as it was not previously fully disclosed to the FDA. And that was seen by the audit. There was a clinical hold placed on this by the FDA and the physician sponsors program. There was a regulatory pathway that needed
to be agreed upon.
There was new clinical development that needed to be conducted. There was
limited and variable number of burn patients across the US and EU, which is still the case.
And we needed a detailed commercial plan to be undertaken. And Lonza, it's
important to note, is not a clinical development organization. It is a contract
manufacturing organization.
And that can't be overstated. They've expressed a significant amount of pleasure in identifying that we will be bringing our clinical development team to take some of that burden off of off of their group, as that's not really their expertise.
We're very pleased with the outcome. How we've addressed these issues? You know when we looked at the due diligence we found, obviously you know that Orphan Drug Designation was granted in 2012. This represents a major value inflection for any program, but certainly defining the size of the Orphan Drug Designation indication is important because with 500 to 2,000 patients that are available for this, we expect clinical studies to be very rapid.
There is a brand-new IND for this program, i.e. ESS-W does not have any of the clinical history at the FDA that PermaDerm/ESS had. And in addressing a lot of the questions that the FDA had from the IND submission in 2012 Lonza was able to get the clinical hold lifted in May of 2014 this year.
So, they spent two years really figuring out all the potential problems that the
FDA had, with respect to this product, which some of it was really led by confusion with the old ESS product and led to the designation of ESS-W, Walkersville, for this product.
And we were very pleased to see that the FDA completely agreed with what was done here and lifted that clinical hold in May of 2014.
...
Lonza has been committed to moving it forward. We’ve seen that over the last 18 months. And we're very pleased now to be able to get directly involved to assist in this process."
Lonza worked for 2 years with the FDA to get the clinical hold removed and get a clean slate and distance from Permaderm's problems.
Here is what GC said:
"So, previously, problems were there were some noncompliance issues significant noncompliance issues in earlier clinical studies. There was certainly questionable credibility of the data generated to date, as some--as it was not previously fully disclosed to the FDA. And that was seen by the audit. There was a clinical hold placed on this by the FDA and the physician sponsors program. There was a regulatory pathway that needed
to be agreed upon.
There was new clinical development that needed to be conducted. There was
limited and variable number of burn patients across the US and EU, which is still the case.
And we needed a detailed commercial plan to be undertaken. And Lonza, it's
important to note, is not a clinical development organization. It is a contract
manufacturing organization.
And that can't be overstated. They've expressed a significant amount of pleasure in identifying that we will be bringing our clinical development team to take some of that burden off of off of their group, as that's not really their expertise.
We're very pleased with the outcome. How we've addressed these issues? You know when we looked at the due diligence we found, obviously you know that Orphan Drug Designation was granted in 2012. This represents a major value inflection for any program, but certainly defining the size of the Orphan Drug Designation indication is important because with 500 to 2,000 patients that are available for this, we expect clinical studies to be very rapid.
There is a brand-new IND for this program, i.e. ESS-W does not have any of the clinical history at the FDA that PermaDerm/ESS had. And in addressing a lot of the questions that the FDA had from the IND submission in 2012 Lonza was able to get the clinical hold lifted in May of 2014 this year.
So, they spent two years really figuring out all the potential problems that the
FDA had, with respect to this product, which some of it was really led by confusion with the old ESS product and led to the designation of ESS-W, Walkersville, for this product.
And we were very pleased to see that the FDA completely agreed with what was done here and lifted that clinical hold in May of 2014.
...
Lonza has been committed to moving it forward. We’ve seen that over the last 18 months. And we're very pleased now to be able to get directly involved to assist in this process."
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