If we follow FDA's steps, it is 36 months from the beginning of Phase 3 clinical trial which may have started at the beginning of 2013. Up to now, we do not know for sure the offical start date of Phase 3. Assuming that everything moves smoothly, it should be 3 years from the official start date.
Note that there are Phase 3 interim reports. If the interim reports show overwhelming positive results, the FDA may grant NeuVax a fast track status which can cut the 36 months into aboyt 18 months.
I think that the company would prepare NeuVax for marketing if it know how positive those results will turn out.
It takes time to gear up production and it also takes time to market the approves NeuVax to oncological centre.
Having said all these, once the FDA approvals, it will shoot up Gale's share price by several hundred percentage points.
If you have the patience and wait, fine. You will be nicely rewarded.
I look at this as an investment stock. I have been buying and holding for more than a year. I will continue to accumulate and hold for the next 2 years.
Gale is not a speculative stock. Nor is it a day-trading stock.
Very strong Buy of Gale shares and hold!!!
You are incorrect the phase III trial did start January 2012...................................Based on the SN-33 booster data, on Jan. 20, 2012, GALE initiated the Phase III PRESENT trial for NeuVax (E75 peptide plus GM-CSF) vaccine in HER2 1+ and 2+ breast cancer patients in the adjuvant setting to prevent recurrence.
Sentiment: Strong Buy
Your timeline looks pretty reasonable, however disagree with the last two sentences . There is plenty of money to be made in these short term moves of 2. 25 to 2.5. That's a 10 percent move that can come in less than a week. Suggest trading around a position so you don't get stuck without any. Going to take allot more than 3kshares to make it worthwhile ...a minimum of 10k I should think or the commissions will be too high.
Your numbers are inaccurate
Gale trial will take 3 yrs Minimum. Then another 6 months at least to collate data and submit and application to the FDA. Then they will give a PDUFA date which will be another 6/9 months minimum. Unless FDA decides to fast track things one is looking at 4/5 years from here to approval
Company has to prepare samples for the FDA approval. They hv to get the commercial manufacturing facilities inspected/approved by the FDA. These things take time. But a company can do some of These during the approval process
If approved, mktg NeuVax won't problem. Patients/oncologists will find it
There is no guarantee a 3/4 trial will be successful
FDA approval is unpredictable for any product unless the trial results are stellar in efficacy and safety
Stocks are there for investing So stocks are investment stocks
GALE is vey much a speculative stock as a lot is depending on a 4 year trial and FDA approval
It also looks like a day trading stock judging from the retail volume.
this stock is fighting short sellers worst than most. On a rumor not nearly as fantastic as GALE's real acheivements pphm went to the moon. Every time GALE starts to climb AF puts out a signal. I don't believe in conspiracies but this one is real. I have 50k shares and plan to continue to buy for the next 3 years. 6-17 should be the longest needed. Possibly the results will be available a little earlier. The price should be 5.00 by this fall if good interims come out. It will slowly climb until p-3 is over. Then it will be straight up.
Sentiment: Strong Buy