Re: GTCB
Following is a transcript of a conversation between Norman Klein (who posts under “snorkle” id on iHub) and GTC’s IR. This transcript was posted by Norman on the Dutch message board for Pharming and was translated into English by mblimon. (I have made minor edits here for clarity.)
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Q: Why the new delay by the EMEA?
A: Briefly, within the EMEA there are a number of sections involved, each of them contributing a part of the information to the CHMP, which gives the final opinion. One of the teams is in charge of the inspection of the facilities. It involves an inspection/review of the upstream facilities (farm), of the downstream facilities (each of the processes of purification/medicine manufacturing/bottling/labeling) and of the clinical trial sites. So it is not limited to the farm. Out of all this information, the inspection team produces a report, which goes to the CHMP. In this case the CHMP had a few questions which had not been fully covered by the report; in other words the inspection team had to go back to GTCB in order to answer these outstanding questions. Although it was not explicitly mentioned, it seems the additional questions mostly concerned the upstream process, since this is the only part of the process which is new to the EMEA.
Obviously, the extra inspection takes time, another report is to be produced, and subsequently has to be reviewed by the CHMP. Hence, the relatively long period in between.
Q: Are any more pitfalls or obstacles on the road expected?
A: No.
Q: Does GTC have a good feeling regarding the outstanding issues and whether they expect approval in February?
A: Yes, though they had expected to get the opinion already in October. However, they have no worries concerning the additional inspection.
Q: What is the status of the open list of questions? [I.e. the status of the EMEA’s evaluation of the answers to the EMEA’s questions that GTC submitted to the EMEA in July —Dew]
A: There is good progress there. Much has been reviewed and GTC is very positive in the sense that they expect the review of the last issues on the list to be completed soon.
Q: How large is the entire GTC file deposited at the EMEA?
A: 60 large volumes.
Q: To what extent will the lack of money will become an issue in the near future?
A: Not an issue. They still have still $27M in cash and do not see any problems there. (They indicated also that they are still a company in the development stage and, if they can make lucrative deals, they will take those into consideration.)
Q: To what extent do politics plays a role?
A: Not at all. The CMHP is a scientific board; if politics would ever play a role, it would not occur at this level, but rather at the level of the EMEA, which could put aside the opinion of the CHMP. [However, Norman notes this has never happened in any EMEA review to date.]
Q: Why are things taking so long in the review process?
A: The total time that the CHMP [as opposed to the EMEA staff] has been effectively reviewing GTC’s application is longer than normal, but does not exceed roughly 1 year. Moreover, GTC has taken its time to respond to the questions as thoroughly and accurately as possible.
Q: Does GTC have the impression that the CHMP is out to postpone the making of difficult decisions?
A: Absolutely not. On the contrary, in spite of a shortage of staff in certain specialized areas, they have put additional staff on GTC’s review. They dedicate a lot of time to GTC and the relations between GTC and the EMEA are excellent and there is a good cooperation. [Norman notes that, if the EMEA had wanted to drop GTC, they would have asked GTC to withdraw their application or would have asked for an unreasonably long time to respond to issues. However, in actuality, we are dealing with a relatively minor delay.]
Q: Why the share price has been going down so fast?
A: GTC does not understand why this has happened because they are now dealing with a delay, which can be explained, whereas the last time the stock price dropped (in March 2005 from the additional list of EMEA questions) there was much more uncertainty about the issues to be clarified and about when GTC’s response would come.
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Overall, GTC made a strong impression and they seem to be very confident of approval. They do not expect any further delays nor any other difficult issues or obstacles on the way to approval.
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