is this why fda delays are getting longer?, page-17

Mulac, the other inspection was around Oct/Nov last year and was an inspection of the manufacturer that supplies specific intermediates to Reddy?s for the fonda synthesis ? it?s a non-GMP/non-DMF part of the process and there were no issues at the inspection that were not dealt with while the inspectors were there. At the time ACL didn?t know whether that second inspection was going to be needed so it is great that it has already been passed.

The first inspection (well it was meant to be) was scheduled for June last year, FDA delayed this to July/August, then Sept/Oct, then November was set and FINALLY they turned up in January.

So now we have management happy to bring out the following:

"While approval has not fallen within our expected time frame, Alchemia is not aware of any outstanding items that stand in the way of approval being granted. Multiple site inspections were completed successfully with the most recent one completed in January this year. As a result, the Company expects there to be no further procedural impediments required prior to approval. Alchemia anticipates the next communication from the FDA to be the product approval itself.

While the overall process for fondaparinux approval has significantly exceeded Alchemia?s original expectations, the Company is confident of the merit of its ANDA for fondaparinux and believes that the extended review period simply reflects the current, long approval times for all generic drugs in the US.

Alchemia?s CEO, Dr Pete Smith, said ?We do not believe that there is anything that we could have done to have expedited the process. We are grateful that all the key steps in the process are complete, in particular the pre-approval inspection of the syringe fill plant. We remain confident of the approvability of our fondaparinux application whilst recognizing that the ultimate timing remains in the hands of the FDA.?

Sskim, as you have point out, the chart is showing us at/near the yearly highs so obviously the expectation of approval is building. Couple that with the timely coverage of SCE, good biotech analysts, and we are set imo.

I tick buy as my sentiment as I am buying and almost got my full 71c fill on Friday:)