You might want to read this again
Repost....
Typical Launch Timeline, from my experience:
A company typically does not make the launch product prior to approval as its too risky and you start eating into the expiration dating of the lots manufactured. Upon approval usually the labeling gets finalized and ordered, typical turnaround time is 4-6 weeks to get labeling. So they updated the labeling December 18th. Then the company would still need to get the paperwork in place to manufacture the batches. Typically on luanch you have to do a scale-up process validation. I am guess that they had to do this for each strength and this entails making 3 batches of each strength so 6 strengths is 18 batches total. Since this was approved in December and I know it is important to the company,I still doubt Nasrat would have cancelled peoples holiday vacation plans so you can pretty much nix the two weeks of the 23rd and 30th. If I had to guess the batches started being manufactured on January 6th, luckily he probably had API from the IR formulation so that did not add to the timeline. If you assume 4 batches a week, which is a lot but probably doable, the manufacturing would have wrapped up this past week. Give two weeks for finalizing all testing and packaging so the batches should be good to ship the week of February 17th. I know this is probably not what everyone wants to hear, but there is a lot to launching a product. This is just my opinion and also a little on the conservative side but we will see.
King to answer your question about the large customer, it really depends on what Lannett agreed too. As they stated it was a contract, this usually involves an agreed upon price for the product and usually is good for one year. The volumes can change through the year and it depends if they agreed upon a forecast. The biggest thing is getting the contract as it usually gives you first right of refusal if someone comes in at a lower price. The wholesalers don't want to have to keep loading a bunch of products and sku's in their warehouses, so once you get the contract usually you are good for a year. So it is definitely a step in the right direction.
These are all just my opinions from my experiences and nothing set in stone. GLTA, our time in ELTP is approaching fast and I have been buying each week to add to my position, trying to get to the 1 Million club, almost there. Salute!!
