Sorry Folks......could not stay away Let's get back to the...

Sorry Folks......could not stay away

Let's get back to the question of a Complete Response Letter

I found this information on the web. A lot of it has been copy/pasted

FYI

Just about 10.5 years ago, the FDA changed the way it would respond to New Drug Applications

Before August 2008 the Centre For Drug Evaluation and Research (CDER), which is under the jurisdiction of the United States Food and Drug Administration had a different way of looking at New Drug Applications NDA's

The sponsor would receive one of the following 3 responses in regards to its NDA

1) An approval letter...which means what it saids

2) An approvable letter...which although it was not an approval, did signal that the company had made a good effort and that the FDA might approve the compound if the drug sponsor met some particular goals

Under the old system, an approvable letter stated that an NDA was basically approvable if certain issues were resolved, indicating that the NDA substantially meets regulatory requirements and the FDA could approve if the applicant submits additional information or agrees to specific conditions.

3) Not approvable letter...that an NDA could not be approved as submitted

A not approvable letter meant that the application could not be approved and might describe deficiencies.



So fast forward to todays regulations

The sponsor would receive one of the following responses in regards to its NDA

1) An approved letter

2) A complete response letter

A complete response letter will state that the FDA cannot approve an NDA in its current form, and will describe specific deficiencies in the application. The deficiencies described therein can be minor (labeling) or major (new clinical trials). When possible, CDER recommends actions that might be taken to place the application in an approval standing.

So what is the difference? For many, this boils down to a matter of transparency. The contents of an approvable letter and a complete response letter are considered proprietary, and the FDA does not divulge the contents of such letters, nor does it issue a press release. Rather, it is in the purview of the sponsoring drug company to release as much information as it wants, with as much specificity as it wishes.

Under the old system, when a company received an approvable letter, although the company might not have said much about the contents, the fact that an approvable letter was received instead of a not approvable letter signaled that the NDA at least had some merit, and that if the company was willing to fulfill certain tasks, the application would likely be approved.

But under the new system, no such subtle signal is being sent. Especially for investors, that means there is an unprecedented reliance on what the company says, and how it may speak about the complete response letter it has received; reading between the lines of a press release may be very telling, if vague, assuming the company says anything substantive about the release.

A statement that the company would be working with the FDA in the future could signal that there is a pathway set up in the letter for eventual approval, and that the company is going to take it

If a press release alludes to a specific issue, such as one of the comparators used in the study, it may signal that more studies are needed.

So as previous posters have alluded to

Starpharma did receive a complete response letter

The company indicated more comparitive data is required (whether it comes from existing data or whether an additional trial needs to be initiated in the USA will be determined soon enough, either by feedback of the "experts or a meeting that will be held sometime........in my opinion March)

Now lets get onto some constructive comments and discussions in reference to Starpharma and not referencing forum participants