Biotech Values

[Regulardoc]

Have a question about a different letter, not the one that TEVA referenced that they would receive by the end of January, which is the one that was released, with some editing today, but seemingly some sort of letter or communication that TEVA has with the FDA signaling that they would receive a letter.

Earlier this month, TEVA notifed all that they were to receive a letter from the FDA. How did they know this? Is it customary for a company to simply request from the FDA where they stand in the approval process in writing, simply to have something in writing? If so, did the FDA simply provide this letter out of courtesy, or is it mandated practice?

If simply an outgrowth of a communication from TEVA to the FDA to simply have something in writing so they could focus their energy on whatever the FDA deemed to be oustanding issues, then I don't feel this letter means a darn thing. If this is a special circumstance, then perhaps it means TEVA is closer.

Again, just perplexed as to TEVA's awareness that they would receive a letter for the FDA by the end of January and is the FDA simply providing TEVA with this info out of courtesy or is it a common practice?

Did MNTA ever request something in writing from the FDA as to their status in the process, or did MNTA simply receive letters "out-of-the-blue?"

Any insights?

Thanks.